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: Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P880086
• Supplement Number: S303
• Date Received: 09/28/2018
• Decision Date: 10/24/2018
• Product Code: DXY
• 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  
Alternate supplier of 100% ethylene oxide gas for device sterilization.