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Device | ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY |
Generic Name | permanent pacemaker Electrode |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S017 |
Date Received | 09/27/2000 |
Decision Date | 05/24/2001 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF THE LITRONIK BATTERY MODEL LIS 3150 IN THE ACTROS+ AND KAIROS PULSE GENERATOR FAMILIES. |