PMA P080006S157

Device
Attain Ability Lead
Applicant
Medtronic, Inc.
PMA number
P080006
Supplement
S157
Product code
OJX
Decision date
2021-02-09
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement
Add an alternate supplier for the specified connector component.

Current openFDA PMA Record#

Device
Attain Ability Lead
Applicant
Medtronic, Inc.
PMA number
P080006
Supplement
S157
Product code
OJX
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date
2021-02-09
Decision code
OK30
Date received
2021-01-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an alternate supplier for the specified connector component.