|
Device | MODELS 5348 AND 5388 EXTERNAL PULSE GENERATORS |
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 | S081 |
Date Received | 07/19/2007 |
Decision Date | 09/28/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES AND INTERNAL COMPONENT UPDATES TO MEDTRONIC MODEL 5348 AND MODEL 5388 EXTERNAL PULSE GENERATORS. |