ANGIO-SEAL VASULAR CLOSURE DEVICE
FDA premarket approval P930038/S058 · decided 2009-05-07
Approval details
- PMA number
- P930038
- Supplement
- S058
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL VASULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2009-04-15
- Decision date
- 2009-05-07
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE EVOLUTION ASSEMBLY.
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