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. |
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Device | 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 | S001 |
Date Received | 05/05/2014 |
Decision Date | 08/01/2014 |
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 |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
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