|
Device | 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 | S078 |
Date Received | 01/27/2022 |
Decision Date | 04/27/2022 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the TactiSys Quartz Equipment SW v1.7.2 software maintenance release to disable the charging of a non-rechargeable Real Time Clock (RTC) battery. |