|
Device | KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2 |
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 | S044 |
Date Received | 07/11/2005 |
Decision Date | 07/26/2005 |
Product Code |
DXY |
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 DESIGN MODIFICATIONS TO THE IPG REED SWITCH. |