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 0.035OTW 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: S015
• Date Received: 09/29/2021
• Decision Date: 03/25/2022
• Product Code: ONU
• Docket Number: 22M-1917
• Notice Date: 08/23/2022
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01927068
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon. The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 180 mm in length in superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2