PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
FDA premarket approval P960043/S049 · decided 2003-11-25
Approval details
- PMA number
- P960043
- Supplement
- S049
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2003-10-27
- Decision date
- 2003-11-25
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE. THESE CHANGES STRENGTHEN THE PROCEDURAL INSTRUCTIONS FOR USING THE DEVICE AND ADD A PRECAUTION TO NOT USE EXCESSIVE FORCE OR TORQUE TO ADVANCE THE DEVICE, STATING THAT SUCH ACTIONS MAY RESULT IN: "IGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR." IN ADDITION TO THESE LABELING CHANGES, YOU HAVE ALSO INDICATED THAT THE PHYSICIAN TRAINING PROTOCOL HAS BEEN REVISED TO
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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 |