FDA.reportPublic FDA data

PMA P140033S076

Device
Assurity MRI, Endurity MRI
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S076
Product code
LWP
Decision date
2022-12-07
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators.

Current openFDA PMA Record#

Device
Assurity MRI, Endurity MRI
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S076
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2022-12-07
Decision code
APPR
Date received
2022-09-08
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators.