PMA P060006S095
- Device
- Express SD Renal Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S095
- Product code
- NIN
- Decision date
- 2018-12-10
- Classification
- Stent, Renal
- Generic name
- STENT, RENAL
- Approval order statement
- Expanding the range of UV light intensity in the manifold bonding process.
Current openFDA PMA Record#
- Device
- Express SD Renal Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S095
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2018-12-10
- Decision code
- OK30
- Date received
- 2018-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expanding the range of UV light intensity in the manifold bonding process.