PMA P050019S032
- Device
- Carotid Wallstent™ Monorail Endoprosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- P050019
- Supplement
- S032
- Product code
- NIM
- Decision date
- 2021-11-15
- Generic name
- Stent, carotid
- Approval order statement
- Alternate adhesive to bond the stent holder to distal inner shaft.
Current openFDA PMA Record#
- Device
- Carotid Wallstent™ Monorail Endoprosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- P050019
- Supplement
- S032
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2021-11-15
- Decision code
- OK30
- Date received
- 2021-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate adhesive to bond the stent holder to distal inner shaft.