FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P950039
·
Supplement: S021
·
Decision Mar 18, 2010
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- THINPREP PROCESSOR 2000/3000
- PMA Number
- P950039
- Supplement Number
- S021
- Device Class
- FDA Class 3
- Product Code
- MKQ
- Generic Name
- Processor, cervical cytology slide, automated
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 18, 2010
- Date Received
- February 25, 2010
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ALTERNATE VENDOR FOR THE MEMBRANE MATERIAL FOR THE MANUFACTURE OF THE THINPREP GYN FILTER USED IN THE THINPREP PROCESSOR 2000 AND THINPREP PROCESSOR 3000.
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 |