ABBOTT AXSYM/TOTAL PSA
FDA premarket approval P910007/S006 · decided 2004-03-03
Approval details
- PMA number
- P910007
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ABBOTT AXSYM/TOTAL PSA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Abbott Laboratories
- Date received
- 2001-06-15
- Decision date
- 2004-03-03
- Days to decision
- 992 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT HEALTH PRODUCTS, INC., BARCELONETA, PUERTO RICO.
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