|
Device | ACTROS FAMILY OF PULSE GENERATORS |
Generic Name | permanent pacemaker Electrode |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S014 |
Date Received | 05/30/2000 |
Decision Date | 06/20/2000 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO SMALLER BLISTER PACKAGING IN THE MANUFACTURING PROCESS OF ALL CURRENT AND FUTURE BIPOLAR PULSE GENERATOR FAMILIES. |