ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S013 · decided 1999-02-12
Approval details
- PMA number
- P930038
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1998-03-05
- Decision date
- 1999-02-12
- Days to decision
- 344 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- Approval for modifications to the suture tensioning mechanism component of the Angio-Seal(TM) device.
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