PMA P140028S062

Device
Innova Vascular Self-Expanding Stent System
Applicant
Boston Scientific Corporation
PMA number
P140028
Supplement
S062
Product code
NIP
Decision date
2020-07-20
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Modifying the process and aids used for stent expansion.

Current openFDA PMA Record#

Device
Innova Vascular Self-Expanding Stent System
Applicant
Boston Scientific Corporation
PMA number
P140028
Supplement
S062
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2020-07-20
Decision code
OK30
Date received
2020-07-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifying the process and aids used for stent expansion.