TACTICATH QUARTZ SET
FDA premarket approval P130026 · decided 2014-10-24
Approval details
- PMA number
- P130026
- Trade name
- TACTICATH QUARTZ SET
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2013-11-29
- Decision date
- 2014-10-24
- Days to decision
- 329 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ® EQUIPMENT. THIS DEVICE IS INDICATED FOR USE IN CARDIACELECTROPHYSIOLOGICAL MAPPING AND FOR THE TREATMENT OF DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED IN CONJUNCTION WITH A COMPATIBLE RADIOFREQUENCY GENERATOR AND THREE-DIMENSIONAL MAPPING SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |