PMA P830045S086

Device
IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC
Applicant
St. Jude Medical, Inc.
PMA number
P830045
Supplement
S086
Product code
KRG
Decision date
2003-05-09
Classification
Cardiovascular
Generic name
Programmer, pacemaker
Approval order statement
APPROVAL FOR PULSE GENERATOR MODELS AND PROGRAMMER SOFTWARE MODEL 3307 V4.4A.

Current openFDA PMA Record#

Device
IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC
Applicant
St. Jude Medical, Inc.
PMA number
P830045
Supplement
S086
Product code
KRG
Generic name
Programmer, pacemaker
Decision date
2003-05-09
Decision code
APPR
Date received
2003-04-14
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR PULSE GENERATOR MODELS AND PROGRAMMER SOFTWARE MODEL 3307 V4.4A.