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: PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Infusyn Therapeutics, LLC; 121 Shelley Dr.; 2h; Hackettstown, NJ 07840
• PMA Number: P080012
• Supplement Number: S028
• Date Received: 05/18/2015
• Decision Date: 07/31/2015
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.