ABBOTT IMX PSA
FDA premarket approval P910007/S003 · decided 1994-10-17
Approval details
- PMA number
- P910007
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT IMX PSA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Abbott Laboratories
- Date received
- 1994-08-29
- Decision date
- 1994-10-17
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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