PMA P960016S085
- Device
- Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables
- Applicant
- St Jude Medical
- PMA number
- P960016
- Supplement
- S085
- Product code
- LPB
- Decision date
- 2020-10-16
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Alternative batch sampling for bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables
- Applicant
- St Jude Medical
- PMA number
- P960016
- Supplement
- S085
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-10-16
- Decision code
- OK30
- Date received
- 2020-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative batch sampling for bacterial endotoxin testing.