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: Corox OTW BP
• Generic Name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• Applicant: BIOTRONIK, INC.; 6024 Jean Road; Lake Oswego, OR 97035
• PMA Number: P070008
• Supplement Number: S107
• Date Received: 08/30/2019
• Decision Date: 10/04/2019
• Product Code: NKE
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for labeling updates to the clinical study summary for the post approval study.