PMA P060006S102
- Device
- Express SD Renal Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S102
- Product code
- NIN
- Decision date
- 2020-11-18
- Generic name
- STENT, RENAL
- Approval order statement
- Change to equipment used for the stent laser cutting process.
Current openFDA PMA Record#
- Device
- Express SD Renal Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S102
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2020-11-18
- Decision code
- OK30
- Date received
- 2020-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to equipment used for the stent laser cutting process.