FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Processor, Cervical Cytology Slide, Automated
PMA: P970018
·
Supplement: S016
·
Decision Jul 2, 2009
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
- S016
- 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
- July 2, 2009
- Date Received
- June 9, 2009
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGES TO THE METHOD OF MANUFACTURING FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS TO REDUCE PRODUCTION COSTS AND IMPROVE CONTROL OF THE MANUFACTURING PROCESS.
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 |