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. |
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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 | S006 |
Date Received | 05/12/1995 |
Decision Date | 10/10/1995 |
Withdrawal Date
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01/31/2007 |
Product Code |
LOB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW ACCELERATED TESTING PROTOCOL TO ESTABLISH THE SHELF-LIFE OF YOUR PRODUCT TO 24 MONTHS |
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