PMA P990025S053
- Device
- EZ Steer Navigational 4mm (TC)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S053
- Product code
- DRF
- Decision date
- 2017-07-27
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- Implementation of the 6-Up Reflow Machine with Recipe Control for Reflow process on all Biosense Webster quad lumen catheter tips at Irwindale
Current openFDA PMA Record#
- Device
- EZ Steer Navigational 4mm (TC)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S053
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2017-07-27
- Decision code
- OK30
- Date received
- 2017-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of the 6-Up Reflow Machine with Recipe Control for Reflow process on all Biosense Webster quad lumen catheter tips at Irwindale