|
Device | DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR |
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 | S091 |
Date Received | 03/02/2009 |
Decision Date | 05/21/2009 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER. |