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 a second indication for use
| Device | PAPNET (R) TESTING SYSTEM |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 1996-01-31 |
| Decision Date | 1996-10-21 |
| PMA | P940029 |
| Supplement | S001 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |