Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable
FDA premarket approval P040042/S052 · decided 2022-11-15
Approval details
- PMA number
- P040042
- Supplement
- S052
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- Date received
- 2022-10-19
- Decision date
- 2022-11-15
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a manufacturing site located at CENTERPIECE S. DE R.L. DE C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada #11530, Tijuana, Baja California, Mexico, 22250 for ethylene oxide sterilization activities.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER (K070011) | Irvine Biomedical,Inc.(Ibi) | 2007-03-20 |