|
Device | TactiCath Quartz Catheter and TactiSys Quartz Equipment |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 |
PMA Number | P130026 |
Supplement Number | S022 |
Date Received | 08/12/2016 |
Decision Date | 09/08/2016 |
Product Code |
OAE |
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 Changes to the environmental specifications and installation of data loggers for environmental monitoring. |