PMA P990025S051

Device: NAVISTAR RMT; NAVISTAR RMT DS CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S051
Product code: DRF
Decision date: 2017-07-17
Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
Generic name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Approval order statement: Approval for transfer of the extrusion process for a subcomponent of the catheters from the Cordis Miami facility to the Webster Juarez manufacturing facility.

Current openFDA PMA Record#

Device: NAVISTAR RMT; NAVISTAR RMT DS CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S051
Product code: DRF
Generic name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Decision date: 2017-07-17
Decision code: APPR
Date received: 2016-11-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for transfer of the extrusion process for a subcomponent of the catheters from the Cordis Miami facility to the Webster Juarez manufacturing facility.