|
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 | S064 |
Date Received | 12/27/2019 |
Decision Date | 01/15/2020 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor software changes (correction of firmware errors) to bring the Prometra II Programmable Pumps (20mL and 40mL) back into specification to match the performance as reflected in the original software requirements. |