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: TUPOS LV/ATX & KRONOS LV-T CRT-DS & COROX OTW STEROID LV PACING LEAD
• Generic Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P050023
• Supplement Number: S002
• Date Received: 10/03/2006
• Decision Date: 10/30/2006
• Product Code: MRM
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.