FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Reader, Cervical Cytology Slide, Automated
PMA: P020002
·
Supplement: S006
·
Decision Jan 23, 2012
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Reader, Cervical Cytology Slide, Automated
- Trade Name
- REVIEW SCOPE MANUAL
- PMA Number
- P020002
- Supplement Number
- S006
- 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
- January 23, 2012
- Date Received
- November 29, 2011
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE REVIEW SCOPE MANUAL+.
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 |