PMA P990025S052

Device: Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S052
Product code: DRF
Decision date: 2017-10-24
Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
Generic name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Approval order statement: Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes.

Current openFDA PMA Record#

Device: Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S052
Product code: DRF
Generic name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Decision date: 2017-10-24
Decision code: APPR
Date received: 2017-06-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for expansion of manufacturing capacity for extrusion and reflow manufacturing processes.