|
Device | MEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S120 |
Date Received | 05/14/2007 |
Decision Date | 06/07/2007 |
Product Code |
NVZ |
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 AN ALTERNATE HARD DISK DRIVE (HDD) USED ON MEDTRONIC MODEL 2090 ?BURBOT? THAT ALSO INCLUDES A MINOR DESIGN CHANGE AND AN ALTERNATE FLOPPY DISC DRIVE (FDD) USED ON BOTH MEDTRONIC MODEL 2090 ?SPLAKE? AND ?BURBOT? CARELINK PROGRAMMERS. |