PMA P990025S026

Device
NAVISTAR RMT CATHETER (4MM)
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S026
Product code
LPB
Decision date
2011-02-03
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC, JUAREZ, MEXICO.

Current openFDA PMA Record#

Device
NAVISTAR RMT CATHETER (4MM)
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S026
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2011-02-03
Decision code
APPR
Date received
2010-10-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC, JUAREZ, MEXICO.