ela Medical Llc

AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.

Cardiovascular Devices

3

Yes

AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.

Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.

BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002

Cardiovascular Devices

3

Yes

AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.

Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.

devices manufactured between April 2003 and August 2004. Model 614 serial numbers: 218XF003, 218XF012, 218XF014, 218XF022, 218XF042, 220XF012, 220XF014, 220XF017, 220XF018, 220XF019, 220XF020, 220XF030, 220XF038, 220XF061, 220XF062, 220XF064, 221XF018, 221XF042, 222XF034, 222XF074, 223XF057, 223XF059 and 223XF061.   Model 624 serial numbers: 238XJ013, 238XJ023, 238XJ037,  244XJ044, 244XJ048, 244XJ062, 244XJ076, 244XJ079,  244XJ092, 246XJ022, 246XJ029, 246XJ048, 246XJ073,  246XJ081, 249XJ028, 249XJ048, 249XJ088, 249XJ160,  249XJ168, 304XJ002, 304XJ018, 304XJ023, 304XJ035,  304XJ041, 304XJ063, 304XJ072, 304XJ081, 304XJ086,  304XJ096, 304XJ100, 304XJ109, 304XJ113, 307XJ015, 307XJ049, 307XJ052, 307XJ057, 307XJ065, 307XJ124,  307XJ142, 307XJ153, 307XJ162, 307XJ171, 307XJ176,  307XJ220, 307XJ234, 307XJ241, 307XJ256, 313XJ013,  313XJ014, 313XJ025, 313XJ027, 313XJ033, 313XJ036, 313XJ038, 313XJ044, 313XJ046, 313XJ068, 313XJ071,  313XJ072, 313XJ081, 313XJ086, 313XJ088, 313XJ090,  313XJ092, 313XJ098, 313XJ104, 313XJ122, 313XJ134,  313XJ136, 313XJ137, 313XJ151, 313XJ158, 313XJ167,  313XJ167, 313XJ170, 313XJ178, 313XJ183, 313XJ191,  313XJ196, 313XJ198, 313XJ199, 313XJ205, 313XJ206,  313XJ210, 313XJ214, 313XJ215, 313XJ217, 313XJ224, 313XJ235, 313XJ235, 313XJ237, 313XJ242, 313XJ242,  313XJ245, 313XJ249, 313XJ250, 313XJ270, 313XJ275,  314XJ003, 314XJ006, 314XJ097, 314XJ102, 314XJ109,  314XJ134, 314XJ136, 314XJ139, 314XJ140, 314XJ148,  314XJ157, 314XJ158, 314XJ160, 314XJ174, 314XJ186,  314XJ187, 314XJ198, 314XJ212, 314XJ230, 314XJ239,  314XJ254, 314XJ256, 314XJ295, 339XJ012, 339XJ015,  339XJ016, 339XJ017, 339XJ019, 339XJ020, 339XJ023,  339XJ031, 339XJ034, 339XJ034, 339XJ037, 339XJ039,  339XJ041, 339XJ042, 339XJ048, 339XJ049, 339XJ050,  339XJ051, 339XJ053, 339XJ055, 339XJ057, 339XJ057,  340XJ001, 340XJ013, 340XJ014, 340XJ017, 340XJ024,  340XJ025, 340XJ030, 340XJ034, 340XJ040, 340XJ044,  340XJ045, 340XJ047, 340XJ051, 340XJ053, 340XJ057, 340XJ061, 340XJ062, 340XJ067, 340XJ076, 340XJ091,  340XJ092, 340XJ098, 340XJ106, 340XJ108, 340XJ117,  342XJ005, 342XJ006, 342XJ009, 342XJ016, 342XJ027,  345XJ002, 345XJ038, 345XJ048, 345XJ049, 345XJ050,  345XJ053, 345XJ064, 345XJ071, 349XJ001, 349XJ013,  349XJ014, 349XJ019, 349XJ020, 349XJ041, 350XJ010,  350XJ024, 350XJ025, 350XJ027, 350XJ030, 350XJ034,  350XJ040, 350XJ043, 350XJ056, 350XJ057, 350XJ060,  350XJ076, 350XJ076, 350XJ077, 350XJ080, 350XJ083,  351XJ003, 351XJ005, 351XJ007, 351XJ014, 351XJ018, 351XJ019, 351XJ020, 351XJ027, 351XJ029, 351XJ038,  351XJ067, 351XJ069, 351XJ075, 351XJ078, 351XJ082,  402XJ005, 402XJ018, 402XJ022, 402XJ023, 402XJ024,  402XJ026, 402XJ045, 402XJ053, 402XJ060, 402XJ061,  402XJ066, 402XJ074, 402XJ076, 402XJ078, 402XJ080,  402XJ085, 402XJ086, 402XJ087, 402XJ088, 403XJ007,  403XJ008, 403XJ017, 403XJ018, 403XJ026, 403XJ027,  403XJ031, 403XJ034, 403XJ040, 403XJ048, 403XJ050,  403XJ054, 403XJ060, 403XJ073, 403XJ086, 403XJ093,  403XJ095, 403XJ098, 403XJ100, 403XJ104, 403XJ105,  403XJ107, 405XJ003, 405XJ013, 405XJ030, 405XJ049,  405XJ053, 405XJ056, 405XJ067, 405XJ070, 406XJ031,  406XJ033, 406XJ035, 406XJ036, 406XJ039, 406XJ040, 406XJ044, 406XJ065, 406XJ069, 406XJ069, 406XJ070,  406XJ075, 407XJ035, 409XJ007, 409XJ009, 409XJ012,  409XJ017, 409XJ018, 409XJ020, 409XJ032, 409XJ034,  409XJ035, 409XJ037, 409XJ041, 409XJ043, 409XJ044,  409XJ046, 409XJ049, 409XJ052, 409XJ053, 409XJ054,  409XJ059, 410XJ004, 410XJ022, 410XJ026, 410XJ028,  410XJ030, 411XJ025, 411XJ035, 411XJ036, 411XJ042,  411XJ045, 411XJ049, 411XJ050, 411XJ054, 411XJ055,  411XJ057, 413XJ001, 413XJ004, 413XJ005, 413XJ006,  413XJ007, 413XJ009, 413XJ016, 413XJ017, 413XJ032,  413XJ040, 413XJ044, 413XJ049, 413XJ050, 413XJ051,  413XJ052, 413XJ054, 413XJ056, 413XJ061, 413XJ062,  413XJ067, 414XJ005, 414XJ009, 414XJ017, 414XJ037,  414XJ038, 414XJ039, 414XJ042, 414XJ047, 414XJ050,  414XJ063, 414XJ070, 414XJ074, 414XJ085, 414XJ093,  414XJ101, 414XJ102, 414XJ105, 414XJ107, 415XJ005,  415XJ022, 415XJ024, 415XJ033, 415XJ035, 415XJ037,  415XJ046, 415XJ068, 415XJ071, 415XJ094, 416XJ021,  416XJ035, 416XJ071, 417XJ057, 417XJ059, 417XJ064 and 418XJ010.

Cardiovascular Devices

3

Yes

Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.

Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

devices manufactured between April 2003 and August 2004. Model 615 serial number: 237XG065.   Model 625 serial numbers: 243XI009, 243XI060, 243XI075, 243XI089, 246XI019, 246XI031, 246XI076, 249XI044, 249XI045,  249XI093, 249XI106, 249XI123, 249XI134, 304XI069,  304XI070, 304XI087, 304XI095, 304XI117, 307XI016,  307XI040, 307XI041, 307XI050, 307XI053, 307XI093, 307XJ016, 312XI007, 312XI009, 312XI016, 312XI033, 312XI033, 312XI041, 312XI095, 312XI097, 312XI124, 402XI027, 402XI070, 404XI007, 404XI010, 404XI028, 404XI029, 404XI031, 404XI044, 409XI001, 409XI007,  409XI013, 409XI015, 409XI018, 413XI004, 414XI017 and 415XI025.

Cardiovascular Devices

3

Yes

Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.

Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

devices manufactured between April 2003 and August 2004. Model 617 serial numbers: 241XH059, 305XH005 and 305XH014.   Model 627 serial numbers: 330YA541, 348YA563, 348YA571,  348YA573, 348YA576, 350YA594, 407YA604, 407YA630,  407YA635, 407YA644, 411YA001, 411YA002, 411YA011,  411YA014, 411YA015, 411YA016 and 418YA029.

Cardiovascular Devices

3

Yes

Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.

Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.