|
Device | MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S023 |
Date Received | 03/12/2002 |
Decision Date | 03/15/2002 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TWO CHANGES IN THE MANUFACTURING PROCESS INVOLVING THE EPOXY DISPENSE PROGRAM AND THE WIRE BOND LOOP PROGRAM. |