PMA P120020S028

Device
Supera Peripheral Stent System
Applicant
Abbott Vascular (Idef Technologies Inc)
PMA number
P120020
Supplement
S028
Product code
NIP
Decision date
2022-11-22
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Approval for a change in formulation and supplier of a delivery system tubing component.

Current openFDA PMA Record#

Device
Supera Peripheral Stent System
Applicant
Abbott Vascular (Idef Technologies Inc)
PMA number
P120020
Supplement
S028
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2022-11-22
Decision code
APPR
Date received
2022-09-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change in formulation and supplier of a delivery system tubing component.