ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S005 · decided 1997-05-01
Approval details
- PMA number
- P930038
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1997-04-16
- Decision date
- 1997-05-01
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- CHANGE TO THE INDICATIONS FOR USE FOR THE ANGIO-SEAL(TM) DEVICE. THE ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE IS NOW INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR INTERVENTIONAL PROCEDURES USING AN RETROGRADE APPROACH AND AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.
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