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: FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL)
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Abbott Medical; 2375 MORSE AVENUE; Plymouth, MN 55442
• PMA Number: P110016
• Supplement Number: S022
• Date Received: 09/01/2015
• Decision Date: 09/14/2015
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
REDUCTION IN BACTERIAL ENDOTOXIN TESTING FREQUENCY FOR THE FLEXABILITY ABLATION CATHETERS MANUFACTURED IN PLYMOUTH, MN.