|
Device | SYNCHRONY MODEL 2020T PULSE GENERATOR |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S097 |
Date Received | 10/07/2003 |
Decision Date | 10/31/2003 |
Product Codes |
DTB DXY KRG |
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 MODIFICATION TO THE MODEL 3510 PROGRAMMER PLATFORM BY ADDING A VIDEO DISPLAY OUT PORT AND THE ADDITION OF A NEW VIDEO CABLE, MODEL 3134. |