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: LEXOS/LUMOS ICDS
• Generic Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P000009
• Supplement Number: S041
• Date Received: 08/20/2010
• Decision Date: 09/17/2010
• Product Code: MRM
• 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  
NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.