Worldheart, Inc.
Country not established
- Devices
- 1
What Worldheart, Inc. makes
Worldheart, Inc. manufactures the NOVACOR Left Ventricular Assist System (LVAS), a mechanical circulatory support device designed for patients with advanced heart failure requiring long-term ventricular assistance.
The NOVACOR LVAS is classified as a Class III medical device under FDA regulations and is authorised through a Premarket Approval (PMA) application. The company is based in the United States.
Catalogue
Novacor Lvas Ref P980012
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Worldheart, Inc. have in the registry?
The registry currently lists 1 device for Worldheart, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Worldheart, Inc.'s devices?
Among its 1 most recently registered device, Worldheart, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Worldheart, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Worldheart, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Worldheart, Inc. in the registry?
The most recently registered devices listed for Worldheart, Inc. include NOVACOR LVAS.