IMMUNO 1 COMPLEXED PSA ASSAY
FDA premarket approval P990055/S005 · decided 2002-09-04
Approval details
- PMA number
- P990055
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMMUNO 1 COMPLEXED PSA ASSAY
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2002-03-28
- Decision date
- 2002-09-04
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR LABELING CHANGES. THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY. THERE IS NO CHANGE IN THE INDICATION FOR USE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.