Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | LEGEND PLUS FAMILY OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P930022 |
Supplement Number | S007 |
Date Received | 07/28/2008 |
Decision Date | 11/21/2008 |
Product Code |
NVZ |
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 COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE. UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS. |
|
|