TheraSphere
FDA premarket approval P200029/S001 · decided 2021-05-14
Approval details
- PMA number
- P200029
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-04-15
- Decision date
- 2021-05-14
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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