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: Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD
• Generic Name: Pulse generator, permanent, implantable
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P880086
• Supplement Number: S270
• Date Received: 01/27/2016
• Decision Date: 02/22/2016
• Product Code: NVZ
• 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  
Implementation of a visual inspection criterion used during the manufacturing of the hybrid assemblies.