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: Tendril MRI Lead
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P140033
• Supplement Number: S040
• Date Received: 10/02/2018
• Decision Date: 10/31/2018
• Product Codes: LWP NVN
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Update to the cleaning process for incoming components.