FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P970018
·
Supplement: S014
·
Decision Nov 7, 2008
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- PREPSTAIN SYSTEM
- PMA Number
- P970018
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- MKQ
- Generic Name
- Processor, cervical cytology slide, automated
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 7, 2008
- Date Received
- July 21, 2008
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A DESIGN CHANGE TO IMPROVE SHIELDING OF THE HORIZONTAL INTERFACE BOARD AND ACCOMPANYING LABELING CHANGES TO CLARIFY PRECAUTIONS AND INSTRUCTIONS.
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 |
|---|---|---|---|
| MKQ | Processor, Cervical Cytology Slide, Automated | FDA class 3 | Unknown |