PMA P200029S004
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S004
- Product code
- NAW
- Decision date
- 2022-12-02
- Generic name
- Microspheres radionuclide
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S004
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2022-12-02
- Decision code
- APPR
- Date received
- 2022-11-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.