TACTICATH QUARTZ SET
FDA premarket approval P130026/S014 · decided 2016-02-01
Approval details
- PMA number
- P130026
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TACTICATH QUARTZ SET
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2016-01-07
- Decision date
- 2016-02-01
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Acceptance of an alternate supplier for proximal optical fiber components and acceptance of a proposed rework process for distal optical fiber components.
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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 |