PMA P200029S001
- Device
- TheraSphere™
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S001
- Product code
- NAW
- Decision date
- 2021-05-14
- Generic name
- Microspheres radionuclide
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- TheraSphere™
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S001
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2021-05-14
- Decision code
- APPR
- Date received
- 2021-04-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.