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: ICS 3000/ RENAMIC PROGRAMMERS
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P000009
• Supplement Number: S059
• Date Received: 09/24/2014
• Decision Date: 10/21/2014
• Product Codes: NVZ NKE NIK LWS
• 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  
CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES.