BD FOCALPOINT GS IMAGING SYSTEM
FDA premarket approval P950009/S021 · decided 2016-06-17
Approval details
- PMA number
- P950009
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD FOCALPOINT GS IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2016-05-19
- Decision date
- 2016-06-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Changes to the printed circuit board reported in this supplement in conjunction with the changes to replace VIC chip and change of manufacturing supplier qualify.
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