|
Device | MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE |
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 | S071 |
Date Received | 08/10/1995 |
Decision Date | 03/13/1996 |
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 AN ALTERNATE STERILIZATION PROCESS |