PMA P110040S004

Device
COMPLETE SE VASCULAR STENT SYSTEM
Applicant
Medtronic Vascular
PMA number
P110040
Supplement
S004
Product code
NIP
Decision date
2014-02-28
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
MULTIPLE CHANGES IN THE STENT PROCESSING.

Current openFDA PMA Record#

Device
COMPLETE SE VASCULAR STENT SYSTEM
Applicant
Medtronic Vascular
PMA number
P110040
Supplement
S004
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2014-02-28
Decision code
OK30
Date received
2014-01-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MULTIPLE CHANGES IN THE STENT PROCESSING.