PMA P950039S029
- Device
- THIN PREP PROCESSORS
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S029
- Product code
- MKQ
- Decision date
- 2014-09-12
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- THE FOLLOWING TEN CHANGES: QUALITY CONTROL (QC) INSTRUCTIONS FOR MICROSCOPE SLIDES INK AND CHIP, ADD A NEW FRICTION FEEDER EQUIPMENT, TP-00372 DOCUMENTATION UPDATE, ELECTRICAL SAFETY TESTING, TRANSFER OF LEGACY (LEGACY PMR) DOCUMENTATION INTO AGILE DOCUMENT CONTROL SYSTEM, INSTRUCTION CLARIFICATION REGARDING AIR VENT HOLES DURING MACHINE ASSEMBLY, MECHANICAL DRIVER BOARDS TESTING, PRESERVCYT QC TESTING, CHANGE IN OWNERSHIP OF LCD BOARD MANUFACTURER, AND IMPROVEMENT TO FIXTURES USED IN THE SCREEN PRINTING PROCESS (SQUEEGEE).
Current openFDA PMA Record#
- Device
- THIN PREP PROCESSORS
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S029
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2014-09-12
- Decision code
- OK30
- Date received
- 2014-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THE FOLLOWING TEN CHANGES: QUALITY CONTROL (QC) INSTRUCTIONS FOR MICROSCOPE SLIDES INK AND CHIP, ADD A NEW FRICTION FEEDER EQUIPMENT, TP-00372 DOCUMENTATION UPDATE, ELECTRICAL SAFETY TESTING, TRANSFER OF LEGACY (LEGACY PMR) DOCUMENTATION INTO AGILE DOCUMENT CONTROL SYSTEM, INSTRUCTION CLARIFICATION REGARDING AIR VENT HOLES DURING MACHINE ASSEMBLY, MECHANICAL DRIVER BOARDS TESTING, PRESERVCYT QC TESTING, CHANGE IN OWNERSHIP OF LCD BOARD MANUFACTURER, AND IMPROVEMENT TO FIXTURES USED IN THE SCREEN PRINTING PROCESS (SQUEEGEE).