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: Sterallex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: The Spectranetics Corp.; 6531 Dumbarton Cir.; Fremont, CA 94555
• PMA Number: P160049
• Supplement Number: S021
• Date Received: 05/08/2023
• Decision Date: 05/23/2023
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Balloon processing changes.