LIVEWIRE TC ABLATION CATHETER
FDA premarket approval P960016/S041 · decided 2013-08-22
Approval details
- PMA number
- P960016
- Supplement
- S041
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIVEWIRE TC ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2013-02-01
- Decision date
- 2013-08-22
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR CHANGES TO 1) UPDATE THE MANUFACTURING PROCEDURE TO ALLOW FOR THE USE OF A MOTORIZED STYLET FEEDER TO PUSH THE STYLET THROUGH THE CATHETER LUMEN FOR ELECTRODE STRINGING; AND 2) ADD AN ADDITIONAL STRINGING STYLET OPTION TO THE MANUFACTURING PROCEDURE.
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