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PMA P960013S114

Device
Tendril STS
Applicant
ABBOTT MEDICAL
Product code
NVN
Decision date
2020-12-16
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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
Tendril STS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S114
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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.