PMA P040014S015

Device: THERAPY ABLATION CATHETER
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S015
Product code: LPB
Decision date: 2011-01-11
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.

Current openFDA PMA Record#

Device: THERAPY ABLATION CATHETER
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S015
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2011-01-11
Decision code: APPR
Date received: 2010-11-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.