THE PERCLOSE A-T (AUTO TIE) SMC DEVICE
FDA premarket approval P960043/S041 · decided 2002-08-21
Approval details
- PMA number
- P960043
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THE PERCLOSE A-T (AUTO TIE) SMC DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2002-07-26
- Decision date
- 2002-08-21
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR A DEVICE NAME CHANGE, COMPANY NAME CHANGE, AND LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE A-T (AUTO TIE) SUTURE MEDIATED CLOSURE (SMC) DEVICE AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE PERCLOSE A-T 6 FR. SMC SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION
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