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: Absorb GTi Bioresorbable Vascular Scaffold (BVS) System
• Generic Name: Absorbable coronary drug-eluting stent
• Applicant: Abbott Vascular, Inc.; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P150023
• Supplement Number: S009
• Date Received: 05/17/2017
• Decision Date: 06/23/2017
• Withdrawal Date: 05/11/2023
• Product Code: PNY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.