LIVEWIRE TC CARDIAC ABLATION SYSTEM
FDA premarket approval P960016/S043 · decided 2014-03-12
Approval details
- PMA number
- P960016
- Supplement
- S043
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIVEWIRE TC CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2013-09-19
- Decision date
- 2014-03-12
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL TO SEMI-AUTOMATE THE PROCESS TO DECORE THE MANDREL FROM THE CATHETER SHAFT SUBASSEMBLY.
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