|
Device | LIVEWIRE TC CARDIAC ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S003 |
Date Received | 06/28/1999 |
Decision Date | 12/13/1999 |
Product Code |
LPB |
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 a change in sterilization process from 12% EtO/88% CFC to 100% EtO (while at the same time transferring the sterilization to an outside contract sterilization facility). |