BD FOCALPOINT GS IMAGING SYSTEM
FDA premarket approval P950009/S012 · decided 2010-09-16
Approval details
- PMA number
- P950009
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BD FOCALPOINT GS IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2010-08-17
- Decision date
- 2010-09-16
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.