|
Device | MEDTRONIC(R) THERA(TM) PULSE GENERATORS |
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 | S038 |
Date Received | 04/11/1995 |
Decision Date | 05/23/1995 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |