|
Device | SYNCHROMED II IMPLANTABLE INFUSION PUMPS/INTRA-ARTERIAL VASCULAR CATHETERS/VASCULAR CATHETERS/INDURA 1P INTRATHECAL |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S144 |
Date Received | 12/07/2010 |
Decision Date | 01/05/2011 |
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 | No |
Recalls | CDRH Recalls |
Approval Order Statement UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA. |