|
Device | GEM ICD/IPG |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S051 |
Date Received | 11/05/2001 |
Decision Date | 12/11/2001 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS. |