ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S021 · decided 1999-09-10
Approval details
- PMA number
- P930038
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1999-08-23
- Decision date
- 1999-09-10
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- The 30-Day Notice requested a change from 10 weeks to 24 weeks as the maximum duration time between the molding date of the anchor and the sterilization date of the finished device that includes the anchor.
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