|
Device | AFFINITY DR & AFFINITY SR PULSE GENERATORS |
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 | S051 |
Date Received | 07/30/1998 |
Decision Date | 01/21/1999 |
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 Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer. |