PMA P040014S046

Device: Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S046
Product code: LPB
Decision date: 2022-11-15
Generic name: Cardiac ablation percutaneous catheter
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: Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S046
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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.