|
Device | PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Infusyn Therapeutics, LLC 121 Shelley Drive 2H Hackettstown, NJ 07840 |
PMA Number | P080012 |
Supplement Number | S001 |
Date Received | 03/06/2012 |
Decision Date | 05/03/2012 |
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 THE POST-APPROVAL STUDY PROTOCOL. |