PMA P990025S017

Device
NAVISTAR RMT CATHETERS
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S017
Product code
LPB
Decision date
2009-08-10
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
APPROVAL FOR A THREE (3) YEAR OF SHELF LIFE FOR THE CATHETER.

Current openFDA PMA Record#

Device
NAVISTAR RMT CATHETERS
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S017
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2009-08-10
Decision code
APPR
Date received
2009-02-18
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A THREE (3) YEAR OF SHELF LIFE FOR THE CATHETER.