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: Prostar XL 10F Percutaneous Vascular Surgical System
• Generic Name: Device, hemostasis, vascular
• Applicant: Abbott Vascular, Inc.; 400 Saginaw Dr.; Redwood, CA 94063
• PMA Number: P960043
• Supplement Number: S093
• Date Received: 06/09/2016
• Decision Date: 07/01/2016
• 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  
Modification to the pre-sterile Sheath-Guide tensile strength acceptance criteria.