PMA P990065S008
- Device
- SIR-SPHERES MICROSPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S008
- Product code
- NAW
- Decision date
- 2015-02-27
- Generic name
- Microspheres radionuclide
- Approval order statement
- ADDITION OF A NEW CLEANROOM WITH TWO NEW PRODUCTION HOT CELLS AND ASSOCIATED EQUIPMENT TO EXISTING MANUFACTURING SPACE.
Current openFDA PMA Record#
- Device
- SIR-SPHERES MICROSPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S008
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2015-02-27
- Decision code
- OK30
- Date received
- 2015-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW CLEANROOM WITH TWO NEW PRODUCTION HOT CELLS AND ASSOCIATED EQUIPMENT TO EXISTING MANUFACTURING SPACE.