NOVACOR LVAS
FDA premarket approval P980012 · decided 1998-09-29
Approval details
- PMA number
- P980012
- Trade name
- NOVACOR LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Worldheart, Inc.
- Date received
- 1998-04-24
- Decision date
- 1998-09-29
- Days to decision
- 158 days
- Decision code
- APWD
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Oakland, CA
- Statement
- Approval for the Novacor(R) LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The LVAS is indicated for use both inside and outside the hospital.
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