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: ISOFLEX OPTIM FAMILY OF LEADS
• Generic Name: Permanent defibrillator electrodes
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P960030
• Supplement Number: S024
• Date Received: 10/29/2008
• Decision Date: 11/26/2008
• Product Code: NVY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ELIMINATION OF THE PLASMA PRIMING PROCESS.