THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA premarket approval P960043/S030 · decided 2001-02-02
Approval details
- PMA number
- P960043
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2000-12-26
- Decision date
- 2001-02-02
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE MULTI-LUMEN STRUCTURE OF THE SHEATH (FROM 5 LUMENS TO 3 LUMENS), AS WELL AS COMBINING THE EXIT RAMP AND PEBAX BEADING INTO A SINGLE INJECTION MOLDED PEBAX COMPONENT TO SIMPLIFY THE MANUFACTURING PROCESS. THESE MODIFICATIONS APPLY TO BOTH THE CLOSER 6 FR. SMC SYSTEM AND THE CLOSER S 6 FR. SMC SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |