|
Device | TactiCath Contact Force Ablation Catheter, Sensor Enabled |
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 | S043 |
Date Received | 03/12/2019 |
Decision Date | 04/10/2019 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the reduction of the concentration of IPA in all TactiCath SE manufacturing. |