LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S
FDA premarket approval P960016/S040 · decided 2013-02-19
Approval details
- PMA number
- P960016
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2012-12-17
- Decision date
- 2013-02-19
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS TO THE MATERIALS IN THE EXTENSION CABLES COMPATIBLE WITH THE LIVEWIRE TC STEERABLE AND SAFIRE STEERABLE CARDIAC ABLATION CATHETERS.
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