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 HV Leads
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P950022
• Supplement Number: S132
• Date Received: 05/08/2020
• Decision Date: 06/04/2020
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to include long-term safety and effectiveness data from the Cardiac Lead Assessment Study in the device labeling.