|
Device | Prometra Programmable Infusion Pump System |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Algorithm Sciences, Inc. 121 Shelley Drive 2H Hackettstown, NJ 07840 |
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. |