PMA P990025S025

Device
NAVISTAR CATHETER, INTERFACE CABLES
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S025
Product code
LPB
Decision date
2010-10-01
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.

Current openFDA PMA Record#

Device
NAVISTAR CATHETER, INTERFACE CABLES
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S025
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2010-10-01
Decision code
APPR
Date received
2010-03-02
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.