ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P930038/S075 · decided 2015-03-26
Approval details
- PMA number
- P930038
- Supplement
- S075
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2015-02-25
- Decision date
- 2015-03-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- ALTERNATE DOSE AUDIT STERILITY TESTING VENDOR.
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