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 | INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 65 William Street Suite 2000 Wellesley, MA 02481 |
PMA Number | P800036 |
Supplement Number | S015 |
Date Received | 09/16/1987 |
Decision Date | 09/20/1995 |
Withdrawal Date
|
03/12/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGE IN LABELING TO INCLUDE EPIDURAL AND INTRATHECAL ADMINISTRATION OF INFUMORPH 200 & 500 CII (PRESERVATIVE-FREE MORPHINE) IN PATIENTS SUFFERING FROM SEVERE AND PROLONGED PAIN WHO ARE NO LONGER RESPONSIVE TO CONVENTIONAL FORMS OF ANALGESIA |
|
|