ARCHITECT TOTAL PSA
FDA premarket approval P910007/S028 · decided 2011-05-11
Approval details
- PMA number
- P910007
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2011-04-18
- Decision date
- 2011-05-11
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- ADDITION OF A QUALITY CONTROL TEST METHOD AND ADDITION OF AN ALTERNATE MANUFACTURING MATERIAL (POLYPROPYLENE RESIN) AND AN ALTERNATE VENDOR.
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