|
Device | 5846 DISPOSABLE PATIENT CABLE |
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 | S121 |
Date Received | 05/08/2013 |
Decision Date | 06/06/2013 |
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 STERILIZATION DOSE PARAMETER CHANGES FOR THE MODELS 5846 A AND 5846 AL AND MODELS 5846 V AND 5846 VL DISPOSABLE PATIENT CABLES. |