PMA P060006S103
- Device
- Express SD Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S103
- Product code
- NIN
- Decision date
- 2022-02-25
- Generic name
- STENT, RENAL
- Approval order statement
- Introduction of parametric release for the BSC2000-2 Ethylene Oxide Sterilization Cycle at the BSC Coventry, RI Facility.
Current openFDA PMA Record#
- Device
- Express SD Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S103
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2022-02-25
- Decision code
- OK30
- Date received
- 2022-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of parametric release for the BSC2000-2 Ethylene Oxide Sterilization Cycle at the BSC Coventry, RI Facility.