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 IMPLANTABLE PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Algorithm Sciences, Inc. 121 Shelley Drive 2H Hackettstown, NJ 07840 |
PMA Number | P080012 |
Supplement Number | S016 |
Date Received | 04/05/2013 |
Decision Date | 07/02/2013 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE CANNULA STRAIN RELIEF AND FILTER SEAL, WHICH ARE BOTH COMPONENTS OF THE IMPLANTABLE PUMP. |
|
|