|
Device | TRILOGY DC + PULSE GENERATOR, MODEL 2318L |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S040 |
Date Received | 11/08/1996 |
Decision Date | 01/10/1997 |
Product Code |
DXY |
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 THE TRILOGY DC+ MODEL 2318L PULSE GENERATOR WITH MODEL 3204A FUNCTION PACK FOR USE WITH THE APS II MODEL 30003 PROGRAMMER. |