PMA P990065S006
- Device
- SIR-SPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S006
- Product code
- NAW
- Decision date
- 2012-07-17
- Generic name
- Microspheres radionuclide
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIRTEX SINGAPORE PTE LTD. IN SINGAPORE.
Current openFDA PMA Record#
- Device
- SIR-SPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S006
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2012-07-17
- Decision code
- APPR
- Date received
- 2011-09-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIRTEX SINGAPORE PTE LTD. IN SINGAPORE.