PMA P990025S070

Device: NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S070
Product code: DRF
Decision date: 2022-09-30
Generic name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Approval order statement: Add an additional chamber for the sterilization of catheters and cables at the Isomedix Operation, Inc. (Steris Grand Prairie) facility in Grand Prairie, Texas.

Current openFDA PMA Record#

Device: NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S070
Product code: DRF
Generic name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Decision date: 2022-09-30
Decision code: OK30
Date received: 2022-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an additional chamber for the sterilization of catheters and cables at the Isomedix Operation, Inc. (Steris Grand Prairie) facility in Grand Prairie, Texas.