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 Ballon
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: The Spectranetics Corp.; 6531 Dumbarton Cir.; Fremont, CA 94555
• PMA Number: P160049
• Supplement Number: S007
• Date Received: 09/03/2019
• Decision Date: 09/13/2019
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate 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 updates to the device labeling.