CERVICAL IMAGING SYSTEM
FDA premarket approval P040028/S004 · decided 2009-03-19
Approval details
- PMA number
- P040028
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERVICAL IMAGING SYSTEM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Applicant
- Spectra Science
- Date received
- 2009-02-10
- Decision date
- 2009-03-19
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MWM
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE LUMA PROBE COVER FROM TWO YEARS TO THREE YEARS.
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