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: Closer Vascular Sealing System (VSS)
• Generic Name: Device, hemostasis, vascular
• Applicant: Rex Medical, L.P.; 555 E. N. Ln.; Suite 5035; Conshohocken, PA 19428
• PMA Number: P150022
• Supplement Number: S007
• Date Received: 09/11/2018
• Decision Date: 10/01/2018
• 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  
Addition of an alternate vendor for the tipping process.