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: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: The Spectranetics Corp.; 6531 Dumbarton Cir.; Fremont, CA 94555
• PMA Number: P160049
• Supplement Number: S003
• Date Received: 10/01/2018
• Decision Date: 11/16/2018
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a labeling update with 2 year data.