PMA P110035S073
- Device
- EPIC SELF-EXPANDING NITINOL STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S073
- Product code
- NIO
- Decision date
- 2024-11-26
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- approval for changes to the rework cycle within the stent passivation process
Current openFDA PMA Record#
- Device
- EPIC SELF-EXPANDING NITINOL STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S073
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2024-11-26
- Decision code
- OK30
- Date received
- 2024-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for changes to the rework cycle within the stent passivation process