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: LUMAX ICDS/CRT-DS
• Generic Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P050023
• Supplement Number: S043
• Date Received: 12/23/2010
• Decision Date: 01/20/2011
• 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  
REMOVAL OF THE 72 HOUR STORAGE CONDITION DURING THE HEADER ATTACHMENT PROCESS.