|
Device | MODEL 5441 EPG PLASTIC COVER |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P820003 |
Supplement Number | S088 |
Date Received | 01/12/2009 |
Decision Date | 02/11/2009 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TRANSFERRING OF THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGE PROCESS STEPS FROM MEDTRONIC RICE CREEK FACILITY TO THE CONTRACT MANUFACTURER. |