PMA P950005S068

Device
Webster Diag./Ablation Deflectable Tip Catheter
Applicant
Biosense Webster, Inc.
PMA number
P950005
Supplement
S068
Product code
LPB
Decision date
2017-10-17
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
Transfer the location of activities associated with receiving, inspection, pre-release and final release.

Current openFDA PMA Record#

Device
Webster Diag./Ablation Deflectable Tip Catheter
Applicant
Biosense Webster, Inc.
PMA number
P950005
Supplement
S068
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2017-10-17
Decision code
OK30
Date received
2017-10-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer the location of activities associated with receiving, inspection, pre-release and final release.