LIVEWIRE CARDIAC ABLATION SYSTEM
FDA premarket approval P960016/S035 · decided 2010-12-07
Approval details
- PMA number
- P960016
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIVEWIRE CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2010-10-05
- Decision date
- 2010-12-07
- Days to decision
- 63 days
- Decision code
- OK30
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- ACCEPTANCE OF CHANGES ASSOCIATED WITH THE ELECTRODE TIP BRAZING AND MONITORING PROCESS.
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