|
Device | LiveWire TC Ablation Catheter and Safire Ablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S087 |
Date Received | 04/19/2021 |
Decision Date | 05/18/2021 |
Product Code |
LPB |
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 a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH. |