CentriMag Circulatory Support System
FDA premarket approval P170038/S005 · decided 2020-08-28
Approval details
- PMA number
- P170038
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- CentriMag Circulatory Support System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abbott
- Date received
- 2020-07-31
- Decision date
- 2020-08-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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