ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
FDA premarket approval P930038/S034 · decided 2002-12-20
Approval details
- PMA number
- P930038
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2002-11-05
- Decision date
- 2002-12-20
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR THE ADDITION OF CLINICAL DATA RELATED TO USE OF THE ANGIO-SEAL STS 6FR DEVICE IN DIAGNOSTIC PATIENTS.
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