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 ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Irvine Biomedical, Inc.; 2375 Morse Ave.; Irvine, CA 92614
• PMA Number: P060019
• Supplement Number: S032
• Date Received: 05/15/2015
• Decision Date: 02/24/2016
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a manufacturing site located at Irvine Biomedical, Inc., in Irvine, California.