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. |
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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 | S032 |
Date Received | 10/26/2015 |
Decision Date | 11/24/2015 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement TO MODIFY THE MANUFACTURING PROCEDURE FOR THE PATIENT THERAPY CONTROLLER (PTC) TO REROUTE THE PTC'S POWER CABLE WITHIN THE ASSEMBLY TO PREVENT IT FROM DAMAGE. ADDITIONALLY, UPDATE THE FINAL RELEASE TEST TO ADD A "BOLUS TEST" TO FURTHER VERIFY THE OPERATION OF THE PTC PRIOR TO RELEASE. |
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