|
Device | MEDTRONIC MODEL 5388 & 5348 EXTERNAL 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 | S085 |
Date Received | 08/27/2008 |
Decision Date | 10/17/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA. |