PMA P140028S083

Device
lnnova™ Vascular Self Expanding Stent
Applicant
Boston Scientific Corporation
PMA number
P140028
Supplement
S083
Product code
NIP
Decision date
2025-08-08
Classification
Cardiovascular
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
an alternate supplier of a delivery system component

Current openFDA PMA Record#

Device
lnnova™ Vascular Self Expanding Stent
Applicant
Boston Scientific Corporation
PMA number
P140028
Supplement
S083
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2025-08-08
Decision code
OK30
Date received
2025-07-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an alternate supplier of a delivery system component