PMA P110035S066
- Device
- Epic Self-Expanding Nitinol Vascular Stent with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S066
- Product code
- NIO
- Decision date
- 2021-04-07
- Generic name
- STENT, ILIAC
- Approval order statement
- to automate a process used to stretch a delivery system liner material
Current openFDA PMA Record#
- Device
- Epic Self-Expanding Nitinol Vascular Stent with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S066
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-04-07
- Decision code
- OK30
- Date received
- 2021-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to automate a process used to stretch a delivery system liner material