ABBOTT AXSYM PSA (LIST 7A49)
FDA premarket approval P910007/S002 · decided 1995-03-29
Approval details
- PMA number
- P910007
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM PSA (LIST 7A49)
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Abbott Laboratories
- Date received
- 1994-04-04
- Decision date
- 1995-03-29
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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