|
Device | PROMETRA PROGRAMMABLE IMPLANTABLE PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Infusyn Therapeutics, LLC 121 Shelley Drive 2H Hackettstown, NJ 07840 |
PMA Number | P080012 |
Supplement Number | S017 |
Date Received | 05/03/2013 |
Decision Date | 05/16/2013 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN MRI INFORMATION BRACELET. |