PMA P030009S083

Device
INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS
Applicant
Medtronic, Ireland
PMA number
P030009
Supplement
S083
Product code
MAF
Decision date
2016-03-04
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
Change to the device history recording process.

Current openFDA PMA Record#

Device
INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS
Applicant
Medtronic, Ireland
PMA number
P030009
Supplement
S083
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2016-03-04
Decision code
OK30
Date received
2016-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the device history recording process.