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 |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 65 William Street Suite 2000 Wellesley, MA 02481 |
PMA Number | P800036 |
Supplement Number | S031 |
Date Received | 03/08/1994 |
Decision Date | 12/23/1996 |
Withdrawal Date
|
03/12/2021 |
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 UNFUSAID(TM) 14G INTRASPINAL CATHETER KIT, AN ACCESSORY TO THE INFUSAID IMPLANTABLE INFUSION PUMP. |
|
|