This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for specific computer hardware and software changes for the review station component of the papnet testing system.
| Device | PAPNET (R) TESTING SYSTEM |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 1996-12-23 |
| Decision Date | 1997-06-25 |
| PMA | P940029 |
| Supplement | S003 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940029 | Original Filing | |
| S003 | 1996-12-23 | Normal 180 Day Track |
| S002 | 1996-04-01 | Normal 180 Day Track |
| S001 | 1996-01-31 | Normal 180 Day Track |