FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Reader, Cervical Cytology Slide, Automated
PMA: P940029
·
Supplement: S002
·
Decision Sep 30, 1996
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Reader, Cervical Cytology Slide, Automated
- Trade Name
- PAPNET (R) TESTING SYSTEM
- PMA Number
- P940029
- Supplement Number
- S002
- 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
- September 30, 1996
- Date Received
- April 1, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE MAPPING UNTI USED IN THE PAPNET TESTING SYSTEM
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 |