PMA P060006S096
- Device
- Express SD Premounted Stent System (ESD)
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S096
- Product code
- NIN
- Decision date
- 2019-06-18
- Classification
- Stent, Renal
- Generic name
- STENT, RENAL
- Approval order statement
- Addition of an alternate vendor for stent finishing chemicals.
Current openFDA PMA Record#
- Device
- Express SD Premounted Stent System (ESD)
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S096
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2019-06-18
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate vendor for stent finishing chemicals.