FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Reader, Cervical Cytology Slide, Automated
PMA: P950009
·
Supplement: S016
·
Decision Aug 30, 2012
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Reader, Cervical Cytology Slide, Automated
- Trade Name
- BD FOCALPOINT SLIDE PROFILER
- PMA Number
- P950009
- Supplement Number
- S016
- Device Class
- FDA Class 3
- Product Code
- MNM
- Generic Name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 30, 2012
- Date Received
- July 5, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR CHANGE OF THE SCAN CONTROLLER BOARD FOR THE DEVICE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNM | Reader, Cervical Cytology Slide, Automated | FDA class 3 | Unknown |