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: S002
• Date Received: 01/22/2018
• Decision Date: 03/12/2018
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for process changes related to the coating process.