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. |
|
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 | S050 |
Date Received | 02/06/2018 |
Decision Date | 01/31/2019 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of baclofen (baclofen injection, intrathecal, 500-2000 microgram/mL) to the Prometra Programmable Infusion Pump System indications for use and corresponding labeling changes to the device system. |
|
|