OVATIO

  • Model / Serial
    Product Code: OH61U, OH60U, OH62U
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    OVATIO Models: VR 6250, DR 6550, CRT 6750. || Product Usage: || OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

103 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model Catalog: TV-AB2980-D (Lot serial: FS031814-11)
  • Product Description
    ABDOMINAL STENT GRAFT SYSTEM-OVATION PRIME
  • Manufacturer
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    Instrument Manager Software
  • Manufacturer
  • Model / Serial
    Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Netherlands, and Germany.
  • Product Description
    CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
  • Manufacturer
  • Model / Serial
    All Software Versions
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 || A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
  • Manufacturer
98 more