PMA P990065S004
- Device
- SIR-SPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S004
- Product code
- NAW
- Decision date
- 2008-01-18
- Generic name
- Microspheres radionuclide
- Approval order statement
- APPROVAL FOR A MANUFACTURING AND STERILIZATION SITE LOCATED IN WILMINGTON, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- SIR-SPHERES
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S004
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2008-01-18
- Decision code
- APPR
- Date received
- 2006-05-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING AND STERILIZATION SITE LOCATED IN WILMINGTON, MASSACHUSETTS.