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: Lutonix 035 Drug Coated Balloon PTA Catheter
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: Lutonix; 9409 Science Center Dr.; New Hope, MN 55428
• PMA Number: P130024
• Supplement Number: S021
• Date Received: 12/08/2017
• Decision Date: 02/06/2018
• Product Code: ONU
• 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 of the revised protocol for the post-approval study (PAS) protocol.