HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR
FDA premarket approval P840029/S011 · decided 1993-05-17
Approval details
- PMA number
- P840029
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR
- Applicant
- Maquet Cardiovascular, LLC
- Date received
- 1992-02-04
- Decision date
- 1993-05-17
- Days to decision
- 468 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Wayne, NJ
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