|
Device | SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S114 |
Date Received | 10/01/2009 |
Decision Date | 10/30/2009 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO THE IMPLANT MANUALS FOR THE FOLLOWING SUTURELESS CONNECTOR CATHETERS: MODEL 8709SC INDURA 1P ONE-PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT, AND MODEL 8696SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR. |