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: RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT
• Generic Name: System, pacing, temporary, acute, internal atrial defibrillation
• Applicant: St Jude Medical; 14901 Deveau Pl.; Minnetonka, MN 55345
• PMA Number: P020052
• Supplement Number: S008
• Date Received: 09/15/2011
• Decision Date: 10/13/2011
• Withdrawal Date: 04/17/2015
• Product Code: MTE
• 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  
ELIMINATE THE UV POST TRIM PROCESS.