PMA P990025S033

Device
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S033
Product code
LPB
Decision date
2012-07-25
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.

Current openFDA PMA Record#

Device
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S033
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2012-07-25
Decision code
OK30
Date received
2012-06-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.