PMA P200029S010
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S010
- Product code
- NAW
- Decision date
- 2024-09-24
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- Approval order statement
- for labeling update with the results obtained from the post-approval study
Current openFDA PMA Record#
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S010
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2024-09-24
- Decision code
- APPR
- Date received
- 2024-05-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- for labeling update with the results obtained from the post-approval study