PMA P820076S024

Device
STRATOS LV & STRATOS LV-T-CRT-P'S
Applicant
Biotronik, Inc.
PMA number
P820076
Supplement
S024
Product code
LWP
Decision date
2008-06-02
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.

Current openFDA PMA Record#

Device
STRATOS LV & STRATOS LV-T-CRT-P'S
Applicant
Biotronik, Inc.
PMA number
P820076
Supplement
S024
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2008-06-02
Decision code
APPR
Date received
2008-05-14
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.