PMA P110035S026
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S026
- Product code
- NIO
- Decision date
- 2014-09-17
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE ELECTROPOLISHING FINISHING OPERATION FOR THE EPIC¿ VASCULAR SELF-EXPANDING STENT SYSTEM.
Current openFDA PMA Record#
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S026
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2014-09-17
- Decision code
- APPR
- Date received
- 2014-04-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE ELECTROPOLISHING FINISHING OPERATION FOR THE EPIC¿ VASCULAR SELF-EXPANDING STENT SYSTEM.