PMA P050019S033
- Device
- Carotid Wallstent™ Monorail Endoprosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- P050019
- Supplement
- S033
- Product code
- NIM
- Decision date
- 2021-12-10
- Generic name
- Stent, carotid
- Approval order statement
- Addition of alternative degreaser and grinding emulsion used to manufacturing delivery system components.
Current openFDA PMA Record#
- Device
- Carotid Wallstent™ Monorail Endoprosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- P050019
- Supplement
- S033
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2021-12-10
- Decision code
- OK30
- Date received
- 2021-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative degreaser and grinding emulsion used to manufacturing delivery system components.