PMA P960016S079
- Device
- LIVEWIRE(R) CARDIAC ABLATION SYSTEM
- Applicant
- St Jude Medical
- PMA number
- P960016
- Supplement
- S079
- Product code
- LPB
- Decision date
- 2019-08-22
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.
Current openFDA PMA Record#
- Device
- LIVEWIRE(R) CARDIAC ABLATION SYSTEM
- Applicant
- St Jude Medical
- PMA number
- P960016
- Supplement
- S079
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2019-08-22
- Decision code
- APPR
- Date received
- 2019-06-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.