PMA P060006S100
- Device
- Express SD Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S100
- Product code
- NIN
- Decision date
- 2020-05-19
- Generic name
- STENT, RENAL
- Approval order statement
- Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.
Current openFDA PMA Record#
- Device
- Express SD Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S100
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2020-05-19
- Decision code
- APPR
- Date received
- 2020-03-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.