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: DURATA, OPTISURE FAMILY OF HV LEADS
• Generic Name: Permanent defibrillator electrodes
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P950022
• Supplement Number: S088
• Date Received: 08/10/2015
• Decision Date: 09/03/2015
• Product Code: NVY
• 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  
USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.