IPULSE CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S047 · decided 2007-12-11
Approval details
- PMA number
- P900023
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IPULSE CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2006-11-13
- Decision date
- 2007-12-11
- Days to decision
- 393 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE IPULSE CIRCULATORY SUPPORT SYSTEM, A UNIT THAT WILL SUPPORT PATIENTS IN NEED OF FULL CIRCULATORY SUPPORT USING THE BVS 5000 BLOOD PUMP OR THE AB5000 VENTRICLE, OR PARTIAL VENTRICULAR ASSIST USING THE APPROVED INTRA-AORTIC BALLOON PUMP (IABP). THE DEVICE CONSOLE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IPULSE CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN CONJUNCTION WITH THE ABIOMED AB 5000 VENTRICLE AND THE BVS 5000 BLOOD PUMP.
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