THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
FDA premarket approval P960043/S035 · decided 2001-12-28
Approval details
- PMA number
- P960043
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-11-19
- Decision date
- 2001-12-28
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR A MODIFICATION OF THE CLOSER S SUTURE-MEDIATED CLOSURE (SMC) DEVICE TO ALLOW FOR A PRE-TIED KNOT UPON DEVICE USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED 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 SYSTEM REDUCE
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