PMA P110035S034
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S034
- Product code
- NIO
- Decision date
- 2016-07-20
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Approval for the addition of a sterilization chamber at the Synergy Health Ireland Limited, Tullamore facility.
Current openFDA PMA Record#
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S034
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2016-07-20
- Decision code
- APPR
- Date received
- 2016-01-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a sterilization chamber at the Synergy Health Ireland Limited, Tullamore facility.