Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TACTICATH QUARTZ SET |
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 | S049 |
Date Received | 06/27/2019 |
Decision Date | 07/24/2019 |
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 manufacturing modifications to the crimp joint and the device pouch inspections. |
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