BD FocalPoint GS Imaging System
FDA premarket approval P950009/S022 · decided 2019-09-05
Approval details
- PMA number
- P950009
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD FocalPoint GS Imaging System
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2019-06-05
- Decision date
- 2019-09-05
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for hardware and associated software modifications necessary to achieve compliance to the European Union RoHS Directive.
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