FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P950039
·
Supplement: S017
·
Decision Oct 5, 2006
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- THINPREP 2000 SYSTEM
- PMA Number
- P950039
- Supplement Number
- S017
- 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
- October 5, 2006
- Date Received
- September 5, 2006
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR LABELING CHANGES REGARDING WARNING AND HANDLING/DISPOSAL INSTRUCTIONS FOR THINPREP 2000 PROCESSORS THAT HAVE BEEN CONTAMINATED WITH TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE).
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 |