|
Device | PHILOS FAMILY OF PULSE GENERATORS |
Generic Name | permanent pacemaker Electrode |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S016 |
Date Received | 10/06/2000 |
Decision Date | 10/31/2000 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF ALTERNATIVE COMPONENTS IN THE PHILOS FAMILY OF PULSE GENERATORS, SPECIFICALLY: 1) THE LITRONIK GMBH AND CO. MODEL LIS 3150 BATTERY; AND 2) A LOW TEMPERATURE CO-FIRE CERAMIC (LTCC) SUBSTRATE. |