Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Perclose ProGlide Suture-Mediated Closure System
• Generic Name: Device, hemostasis, vascular
• Applicant: Abbott Vascular, Inc.; 400 Saginaw Dr.; Redwood, CA 94063
• PMA Number: P960043
• Supplement Number: S097
• Date Received: 07/28/2017
• Decision Date: 02/16/2018
• Product Code: MGB
• Docket Number: 18M-0792
• Notice Date: 02/21/2018
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01931956
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Perclose ProGlide SMC System which 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 procedures. The Perclose ProGlide SMC System is used without or, if required, with adjunctive manual compression.1) For access sites in the common femoral artery using 5F to 21F sheaths. For sheath sizes greater than 8F, at least two devices and the pre-close technique are required; and2) For access sites in the common femoral vein using 5F to 24F sheaths.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2