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: OPTIMIZER Smart, OPTIMIZER Smart Mini
• Generic Name: Implantable pulse generator
• Applicant: Impulse Dynamics (Usa), Inc.; 50 Lake Center Executive Pkwy.; 401 Rte. 73 N, Bldg. 50 Suite 100; Marlton, NJ 08053
• PMA Number: P180036
• Supplement Number: S015
• Date Received: 07/22/2022
• Decision Date: 08/18/2022
• Product Code: QFV
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised Conditions of Approval for nonclinical MR testing.