PMA P050019S036
- Device
- Carotid WALLSTENT™ Monorail Endoprosthesis System
- Applicant
- Boston Scientific Corp
- PMA number
- P050019
- Supplement
- S036
- Product code
- NIM
- Decision date
- 2022-11-28
- Generic name
- Stent, carotid
- Approval order statement
- New method for water bath sterilization.
Current openFDA PMA Record#
- Device
- Carotid WALLSTENT™ Monorail Endoprosthesis System
- Applicant
- Boston Scientific Corp
- PMA number
- P050019
- Supplement
- S036
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2022-11-28
- Decision code
- OK30
- Date received
- 2022-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New method for water bath sterilization.