CentriMag Circulatory Support System
FDA premarket approval P170038/S001 · decided 2020-03-20
Approval details
- PMA number
- P170038
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CentriMag Circulatory Support System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abbott
- Date received
- 2020-01-08
- Decision date
- 2020-03-20
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Aproval for a manufacturing site located at Gerresheimer Regensburg GmbH in Pfreimd, Germany for assembling and packaging the blood pump.
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