ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S016 · decided 1998-07-17
Approval details
- PMA number
- P930038
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1998-06-24
- Decision date
- 1998-07-17
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- Approval for labeling changes intended to minimize the occurrence of vesse occlusion events associated iwth use of the device.
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