|
Device | ISOMED PUMP AND INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P990034 |
Supplement Number | S011 |
Date Received | 07/24/2008 |
Decision Date | 10/17/2008 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY. |