PMA P950009S003
- Device
- AUTOPAP SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S003
- Product code
- MNM
- Decision date
- 1999-01-19
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- Approval for removal of the stage three-alarm unit. The device is to be used only on conventionally prepared Pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk." Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.
Current openFDA PMA Record#
- Device
- AUTOPAP SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S003
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 1999-01-19
- Decision code
- APPR
- Date received
- 1998-10-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for removal of the stage three-alarm unit. The device is to be used only on conventionally prepared Pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk." Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.