FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P970018
·
Supplement: S025
·
Decision Nov 8, 2012
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- BD PREPSTAIN SYSTEM
- PMA Number
- P970018
- Supplement Number
- S025
- 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 8, 2012
- Date Received
- May 18, 2012
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A SUPPLIER CHANGE TO THE RAW MICROSOPE SLIDE, A CRITICAL COMPONENT IN THE DEVICE.
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 |