AB5000 CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S048 · decided 2007-12-21
Approval details
- PMA number
- P900023
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AB5000 CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2007-04-23
- Decision date
- 2007-12-21
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE A STATEMENT REGARDING ADDITIONAL IN VITRO RELIABILITY TESTING OF THE PUMP.
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