PMA P040042S052

Device: Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S052
Product code: OAD
Decision date: 2022-11-15
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order 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.

Current openFDA PMA Record#

Device: Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S052
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2022-11-15
Decision code: APPR
Date received: 2022-10-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.