ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
FDA premarket approval P930038/S039 · decided 2004-04-30
Approval details
- PMA number
- P930038
- Supplement
- S039
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2004-04-02
- Decision date
- 2004-04-30
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL TO ADD LANGUAGE THAT INSTRUCTS THE USER IN THE METHOD ASSOCIATED WITH REPUNCTURE OF THE SAME LOCATION OF PREVIOUS ANGIO-SEAL USE WHEN THE PREVIOUS USE OCCURRED IN LESS THAN OR EQUAL TO 90 DAYS.
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