PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM
FDA premarket approval P960043/S048 · decided 2004-02-11
Approval details
- PMA number
- P960043
- Supplement
- S048
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2003-09-08
- Decision date
- 2004-02-11
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR A NAME CHANGE, FROM PERCLOSE AT MONO-GLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM TO PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE PROGLIDE SUTURE MEDIATED CLOSER (SMC) SYSTEMS AND IS 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. SH
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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 |