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: Therapy Cool Path SP Ablation Catheter
• Generic Name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
• Applicant: Irvine Biomedical, Inc.; 2375 Morse Ave.; Irvine, CA 92614
• PMA Number: P060019
• Supplement Number: S049
• Date Received: 09/18/2020
• Decision Date: 10/16/2020
• Product Code: OAD
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Alternative batch sampling for bacterial endotoxin testing.