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.
The 30-day notice requested a change in the approved sterilization process of e-beam to gamma radiation process.
| Device | LAMICEL OSMOTIC CERVICAL DILATOR |
| Generic Name | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination |
| Applicant | Medtronic Xomed, Inc. |
| Date Received | 1999-06-24 |
| Decision Date | 1999-07-09 |
| PMA | P820075 |
| Supplement | S008 |
| Product Code | LOB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |