Note: 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. |
|
Device | LAMICEL(R) OSSMOTIC CERVICAL DILATOR |
Generic Name | dilator, cervical, synthetic, osmotic, pregnancy termination |
Applicant | Medtronic Xomed, Inc. 6743 SOUTHPOINT DR. N. JACKSONVILLE, FL 32216 |
PMA Number | P820075 |
Supplement Number | S005 |
Date Received | 07/05/1991 |
Decision Date | 10/09/1991 |
Withdrawal Date
|
01/31/2007 |
Product Code |
LOB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
|
|