PMA P830045S066

Device: 3500/3510 PROGRAMMER
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S066
Product code: KRG
Decision date: 2000-01-28
Generic name: Programmer, pacemaker
Approval order statement: Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrrogation of implanted St. Jude pacemakers.

Current openFDA PMA Record

Device: 3500/3510 PROGRAMMER
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S066
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2000-01-28
Decision code: APPR
Date received: 1999-07-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrrogation of implanted St. Jude pacemakers.