|
Device | REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S058 |
Date Received | 12/13/1999 |
Decision Date | 12/27/1999 |
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 The device is indicated for the programming of the adjustable parameters of the implantable recorder used in the device. |