PMA P060001S029

Device
Protege GPS Self-expanding Peripheral Stent System
Applicant
Medtronic Vascular, Inc.
PMA number
P060001
Supplement
S029
Product code
NIM
Decision date
2020-08-04
Generic name
Stent, carotid
Approval order statement
Approval for changing a delivery system tensile strength specification.

Current openFDA PMA Record#

Device
Protege GPS Self-expanding Peripheral Stent System
Applicant
Medtronic Vascular, Inc.
PMA number
P060001
Supplement
S029
Product code
NIM
Generic name
Stent, carotid
Decision date
2020-08-04
Decision code
APPR
Date received
2020-05-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changing a delivery system tensile strength specification.