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 OSMOTIC 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 | S009 |
Date Received | 06/24/1999 |
Decision Date | 07/16/1999 |
Withdrawal Date
|
01/31/2007 |
Product Code |
LOB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new sterilization facility located at Sterigenics Intl., Inc., 10811 Withers Cove Park Dr., Charlotte, N.C. |
|
|