PMA P060006S098
- Device
- Express SD Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S098
- Product code
- NIN
- Decision date
- 2019-11-07
- Classification
- Stent, Renal
- Generic name
- STENT, RENAL
- Approval order statement
- Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle.
Current openFDA PMA Record#
- Device
- Express SD Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S098
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2019-11-07
- Decision code
- OK30
- Date received
- 2019-10-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle.