PMA P110035S013
- Device
- EPIC VASCULAR SELF EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S013
- Product code
- NIO
- Decision date
- 2013-05-31
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- ADD IN-PROCESS CONTROLS FOR A COMPONENT BONDING STEP.
Current openFDA PMA Record#
- Device
- EPIC VASCULAR SELF EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S013
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2013-05-31
- Decision code
- OK30
- Date received
- 2013-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD IN-PROCESS CONTROLS FOR A COMPONENT BONDING STEP.