Devices

ELA Rhapsody SR

Model / Serial
Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059, 309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
Product Description
ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
Manufacturer
ela Medical Llc
1 Event
- Recall of ELA Rhapsody SR

Manufacturer

ela Medical Llc

Manufacturer Address
ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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