LIVEWIRE TC AND SAFIRE ABLATION CATHETERS
FDA premarket approval P960016/S048 · decided 2014-09-05
Approval details
- PMA number
- P960016
- Supplement
- S048
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIVEWIRE TC AND SAFIRE ABLATION CATHETERS
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2014-08-06
- Decision date
- 2014-09-05
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR ADDITION OF A NEW INSPECTION STEP TO THE PACKAGE SEALING AND STERILE PACKAGE ASSEMBLY MANUFACTURING PROCEDURES AND ADDITIONAL CLARIFICATIONS TO FINAL PACKAGE INSPECTION FOR SPECIFIC VISUAL INSPECTION PROCEDURE, INCLUDING AN INSPECTION STEP FOR DETECTING WRINKLES.
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510(k) clearances by this applicant
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|---|---|---|
| GuardianTM Burr Hole Cover System (K181382) | St Jude Medical | 2018-07-20 |
| EnSite Velocity Cardiac Mapping System v5.2 (K172396) | St Jude Medical | 2018-04-23 |
| myMerlin(TM) Mobile Application Model APP1001 (K173232) | St Jude Medical | 2017-11-02 |
| 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 |
| MediGuide Technology System (K162643) | St Jude Medical | 2016-12-13 |
| 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 |