|
Device | PROTOS FAMILY OF PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S029 |
Date Received | 11/20/2002 |
Decision Date | 12/20/2002 |
Product Codes |
DTB DXY KRG |
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 REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS. |