PMA P140030S019

Device
Astron
Applicant
Biotronik AG
PMA number
P140030
Supplement
S019
Product code
NIO
Decision date
2025-07-16
Classification
Cardiovascular
Generic name
STENT, ILIAC
Approval order statement
an alternate UV-adhesive

Current openFDA PMA Record#

Device
Astron
Applicant
Biotronik AG
PMA number
P140030
Supplement
S019
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2025-07-16
Decision code
OK30
Date received
2025-06-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an alternate UV-adhesive