CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS
FDA premarket approval P960043/S031 · decided 2001-11-20
Approval details
- PMA number
- P960043
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-01-29
- Decision date
- 2001-11-20
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR THE CLOSER 6 FR. SYSTEMS DURING INTERVENTIONAL CATHETERIZATION (EXPANDED INDICATIONS FOR USE) REQUIRING 7 TO 8 FR. SHEATHS. THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS ARE MODIFIED, AS 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 8 FR. SHEATHS. THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS REDUCED THE TIMES TO HEMOSTASIS, AMBULATI
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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 |