PMA P060006S106
- Device
- Express SD Renal Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S106
- Product code
- NIN
- Decision date
- 2023-03-08
- Classification
- Cardiovascular
- Generic name
- STENT, RENAL
- Approval order statement
- Alternate raw material supplier used in forming stents.
Current openFDA PMA Record#
- Device
- Express SD Renal Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S106
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2023-03-08
- Decision code
- OK30
- Date received
- 2023-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate raw material supplier used in forming stents.