PMA P090003S041
- Device
- EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P090003
- Supplement
- S041
- Product code
- NIO
- Decision date
- 2016-07-13
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Process changes associated with etching, polishing, and cleaning the stent component.
Current openFDA PMA Record#
- Device
- EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P090003
- Supplement
- S041
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2016-07-13
- Decision code
- OK30
- Date received
- 2016-06-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process changes associated with etching, polishing, and cleaning the stent component.