THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS
FDA premarket approval P960043/S038 · decided 2002-04-29
Approval details
- PMA number
- P960043
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2002-03-26
- Decision date
- 2002-04-29
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE SUTURE TRIMMER, AN ACCESSORY DEVICE TO THE CLOSER SYSTEMS PREVIOUSLY APPROVED UNDER PMAS P960043/S027 AND S032. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUTURE TRIMMER AND IS INDICATED, AS AN ACCESSORY DEVICE, FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE CLOSER II 6 FR. SMC SYST
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