PMA P080006S052

Device
ATTAIN ABILITY LEAD
Applicant
Medtronic, Inc.
PMA number
P080006
Supplement
S052
Product code
OJX
Decision date
2013-12-24
Classification
Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement
APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.

Current openFDA PMA Record#

Device
ATTAIN ABILITY LEAD
Applicant
Medtronic, Inc.
PMA number
P080006
Supplement
S052
Product code
OJX
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date
2013-12-24
Decision code
APPR
Date received
2013-04-10
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.