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, Perclose ProStyle Suture-Mediated Closure and Repair System
• Generic Name: Device, hemostasis, vascular
• Applicant: Abbott Vascular, Inc.; 400 Saginaw Dr.; Redwood, CA 94063
• PMA Number: P960043
• Supplement Number: S117
• Date Received: 07/25/2022
• Decision Date: 08/23/2022
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Qualification of manufacturing room (Suite 5) at a higher occupancy of equipment and personnel than the initial qualification.