PMA P030036S074

Device
SELECTSECURE LEAD
Applicant
Medtronic Cardiac Rhythm Disease Management
PMA number
P030036
Supplement
S074
Product code
NVY
Decision date
2014-09-24
Classification
Permanent Defibrillator Electrodes
Generic name
Permanent defibrillator electrodes
Approval order statement
USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.

Current openFDA PMA Record#

Device
SELECTSECURE LEAD
Applicant
Medtronic Cardiac Rhythm Disease Management
PMA number
P030036
Supplement
S074
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2014-09-24
Decision code
OK30
Date received
2014-08-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.