NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT
FDA premarket approval P980012/S003 · decided 2003-01-10
Approval details
- PMA number
- P980012
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT
- Generic name
- Ventricular (assist) bypass
- Applicant
- Worldheart, Inc.
- Date received
- 2002-06-11
- Decision date
- 2003-01-10
- Days to decision
- 213 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Oakland, CA
- Statement
- APPROVAL FOR OPTIONAL USE OF THE RE-DESIGNED EPTFE INFLOW CONDUIT WITH THE NOVACOR N100PC LVAS DEVICE SYSTEM.
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