ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P930038/S067 · decided 2013-04-15
Approval details
- PMA number
- P930038
- Supplement
- S067
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2011-07-05
- Decision date
- 2013-04-15
- Days to decision
- 650 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, INC., IN MINNETONKA, MINNESOTA.
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