SAFIRE CARDIAC ABLATION SYSTEM
FDA premarket approval P960016/S019 · decided 2007-09-24
Approval details
- PMA number
- P960016
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SAFIRE CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2007-08-07
- Decision date
- 2007-09-24
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR LABELING MODIFICATIONS THAT ALLOWS: 1) THE IBI-1500T6 AND T9 CARDIAC ABLATION GENERATORS (EQUIPPED WITH TEMPERATURE MONITORING) TO BE USED WITH THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER AND 2) THE EXTENSION CABLES (PREVIOUSLY APPROVED UNDER P960016/S016 FOR USE WITH THE IBI-1500T6) BE USED WITH THE IBI-1500 T9 RF GENERATOR.
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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 |