FDA.reportPublic FDA data

PMA P140033S060

Device
Assurity MRI and Endurity MRI
Applicant
ABBOTT MEDICAL
Product code
LWP
Decision date
2020-12-16
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for 3T MR Conditional labeling of certain Assurity MRI and Endurity MRI models when combined with a subset (46 cm, 52 cm and 58 cm) of Tendril STS Model 2088TC leads.

Current openFDA PMA Record#

Device
Assurity MRI and Endurity MRI
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S060
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-12-16
Decision code
APPR
Date received
2020-09-29
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for 3T MR Conditional labeling of certain Assurity MRI and Endurity MRI models when combined with a subset (46 cm, 52 cm and 58 cm) of Tendril STS Model 2088TC leads.