|
Device | Livewire TC Cables; Safire Ablation Catheter; Safire Cable |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S077 |
Date Received | 02/14/2019 |
Decision Date | 03/05/2019 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization site located at Sterigenics, 5725 Harold Gatty Drive, Salt Lake City, Utah. |