|
Device | Prometra Programmable Infusion Pump System |
Generic Name | pump, infusion, implanted, programmable |
Applicant | FLOWONIX MEDICAL, INC. 500 international drive suite 200 mt.olive, NJ 07828 |
PMA Number | P080012 |
Supplement Number | S045 |
Date Received | 06/08/2017 |
Decision Date | 08/21/2017 |
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 |
Approval Order Statement Approval for revised protocol for the post-approval study (PAS) protocol. |