ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S020 · decided 1999-12-08
Approval details
- PMA number
- P930038
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1999-07-19
- Decision date
- 1999-12-08
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- Approval for the alternate manufacturing facility located at the Daig Corporation, 14901 DeVeau Place, Minnetonka, Minnesota 55345.
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