SIR-SPHERES MICROSPHERES
FDA premarket approval P990065/S008 · decided 2015-02-27
Approval details
- PMA number
- P990065
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIR-SPHERES MICROSPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2015-01-15
- Decision date
- 2015-02-27
- Days to decision
- 43 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- ADDITION OF A NEW CLEANROOM WITH TWO NEW PRODUCTION HOT CELLS AND ASSOCIATED EQUIPMENT TO EXISTING MANUFACTURING SPACE.
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