- Device
- ARCHITECT TOTAL PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S033
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2011-12-21
- Decision code
- APPR
- Date received
- 2011-11-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.