WORLD HEART NOVACOR N100PC AND N100PCQ :VAS
FDA premarket approval P980012/S006 · decided 2004-07-21
Approval details
- PMA number
- P980012
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WORLD HEART NOVACOR N100PC AND N100PCQ :VAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Worldheart, Inc.
- Date received
- 2004-03-10
- Decision date
- 2004-07-21
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Oakland, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL.
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