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 new accelerated testing protocol to establish the shelf-life of your product to 24 months
| Device | LAMICEL(R) OSSMOTIC CERVICAL DILATOR |
| Generic Name | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination |
| Applicant | Medtronic Xomed, Inc. |
| Date Received | 1995-05-12 |
| Decision Date | 1995-10-10 |
| PMA | P820075 |
| Supplement | S006 |
| Product Code | LOB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Xomed, Inc. 6743 Southpoint Dr. N. jacksonville, FL 32216 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820075 | Original Filing | |
| S009 | 1999-06-24 | Normal 180 Day Track |
| S008 | 1999-06-24 | 30-day Notice |
| S007 | 1995-05-22 | Normal 180 Day Track |
| S006 | 1995-05-12 | Normal 180 Day Track |
| S005 | 1991-07-05 | Normal 180 Day Track |
| S004 | 1988-01-11 | Normal 180 Day Track |
| S003 | ||
| S002 | 1984-12-03 | |
| S001 | 1984-12-03 |