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Device | ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C |
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 | S038 |
Date Received | 08/12/1996 |
Decision Date | 05/13/1999 |
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 AddVent(R) VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus(R) Model 1368 single-pass lead. The indications are specified in Attachment A. |