Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System
FDA premarket approval P960043/S118 · decided 2023-06-02
Approval details
- PMA number
- P960043
- Supplement
- S118
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2022-09-19
- Decision date
- 2023-06-02
- Days to decision
- 256 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for the Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide Suture-Mediated Closure System for closure of multiple access sites in a single femoral vein.The Perclose ProGlide Suture-Mediated Closure System/Perclose ProStyle Suture-Mediated Closure and Repair System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedu
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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 |