NOVACOR LVAS
FDA premarket approval P980012/S001 · decided 1999-12-21
Approval details
- PMA number
- P980012
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVACOR LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Worldheart, Inc.
- Date received
- 1999-06-28
- Decision date
- 1999-12-21
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Oakland, CA
- Statement
- Approval to introduce the Novacor LVAS Compact Controllers with AutoTuning Software.
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