PMA P990025S057

Device
Navistar RMT Catheter
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S057
Product code
DRF
Decision date
2019-03-08
Classification
Catheter, Electrode Recording, Or Probe, Electrode Recording
Generic name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Approval order statement
Alternate qualified supplier of magnet components.

Current openFDA PMA Record#

Device
Navistar RMT Catheter
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S057
Product code
DRF
Generic name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Decision date
2019-03-08
Decision code
OK30
Date received
2019-02-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate qualified supplier of magnet components.