PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM
FDA premarket approval P960043/S080 · decided 2013-04-15
Approval details
- PMA number
- P960043
- Supplement
- S080
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2012-07-20
- Decision date
- 2013-04-15
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR THE PERCLOSE® PROGLIDE¿ SUTURE MEDIATED CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTSWHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21 F SHEATHS; FOR SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE AREREQUIRED.
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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 |