LIVEWIRE(R) CARDIAC ABLATION SYSTEM
FDA premarket approval P960016 · decided 1999-05-04
Approval details
- PMA number
- P960016
- Trade name
- LIVEWIRE(R) CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 1996-05-17
- Decision date
- 1999-05-04
- Days to decision
- 1082 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for the Livewire TC(TM) Cardiac Ablation System. The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways assocated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
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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 |
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| 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 |