ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S004 · decided 1997-04-25
Approval details
- PMA number
- P930038
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1997-03-31
- Decision date
- 1997-04-25
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ANGIO-SEAL(TM) MANUFACTURING PROCESS TO ELIMINATE THE POTENTIAL FOR DAMAGE OF THE SUTURE COMPONENT.
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