PMA P110035S029
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S029
- Product code
- NIO
- Decision date
- 2015-02-09
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- NEW PLASMA UNIT USED DURING THE RACK BONDING PROCESS FOR THE EPIC VASCULAR SELF-EXPANDING NITINOL STENT SYSTEM.
Current openFDA PMA Record#
- Device
- EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S029
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2015-02-09
- Decision code
- OK30
- Date received
- 2015-01-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW PLASMA UNIT USED DURING THE RACK BONDING PROCESS FOR THE EPIC VASCULAR SELF-EXPANDING NITINOL STENT SYSTEM.