LIVEWIRE TC ABLATION CATHETERS
FDA premarket approval P960016/S052 · decided 2015-01-15
Approval details
- PMA number
- P960016
- Supplement
- S052
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIVEWIRE TC ABLATION CATHETERS
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2014-12-22
- Decision date
- 2015-01-15
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR THE ADDITION OF A NEW EFFECTIVE LENGTH INSPECTION.
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|---|---|---|
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| Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (K160335) | St Jude Medical | 2016-12-13 |
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| AutoMark Module (K160218) | St Jude Medical | 2016-12-13 |
| EnSite Precision Cardiac Mapping System v2.0 (K160210) | St Jude Medical | 2016-12-13 |
| Pacel Flow Directed Pacing Catheter (K161873) | St Jude Medical | 2016-11-22 |