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: PMA NIT-OCCLUD PDA
• Generic Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Applicant: Pfm Medical, Inc.; 1916 Palomar Oaks Way Suite 150; Carlsbad, CA 92008
• PMA Number: P120009
• Supplement Number: S003
• Date Received: 10/12/2016
• Decision Date: 12/16/2016
• Product Code: MAE
• Advisory Committee: Cardiovascular
• 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 revised protocol for the post-approval study (PAS) protocol.