PMA P110035S007
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S007
- Product code
- NIO
- Decision date
- 2013-02-20
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- PROCESS CHANGE WITHIN THE EXPANSION AND HEAT SETTING PROCESS FOR THE EPIC STENTS.
Current openFDA PMA Record#
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S007
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2013-02-20
- Decision code
- OK30
- Date received
- 2013-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- PROCESS CHANGE WITHIN THE EXPANSION AND HEAT SETTING PROCESS FOR THE EPIC STENTS.