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 GT1 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: S003
• Date Received: 08/05/2016
• Decision Date: 10/10/2017
• Withdrawal Date: 05/11/2023
• Product Code: PNY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for your premarket approval application (PMA) request that we place your study on hold.