|
Device | LIVEWIRE TC ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S046 |
Date Received | 04/30/2014 |
Decision Date | 04/09/2015 |
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 A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS. |