PMA P950039S031
- Device
- THINPREP PROCESSORS
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S031
- Product code
- MKQ
- Decision date
- 2014-11-20
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR REFORMULATION OF TUBING THAT DELIVERS AIR AND PROCESSING REAGENTS TO THE PATIENTS SAMPLE, A CHANGE TO THE PUMP USED ON THE THINPREP® 3000 (TP3000) AND MODIFICATION OF THE T-2000 HEAD LEVER ASSEMBLY TO REDUCE TOLERANCE STACK-UP.
Current openFDA PMA Record#
- Device
- THINPREP PROCESSORS
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S031
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2014-11-20
- Decision code
- APPR
- Date received
- 2014-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REFORMULATION OF TUBING THAT DELIVERS AIR AND PROCESSING REAGENTS TO THE PATIENTS SAMPLE, A CHANGE TO THE PUMP USED ON THE THINPREP® 3000 (TP3000) AND MODIFICATION OF THE T-2000 HEAD LEVER ASSEMBLY TO REDUCE TOLERANCE STACK-UP.