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) OSMOSTIC 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 | S007 |
Date Received | 05/22/1995 |
Decision Date | 01/03/1996 |
Withdrawal Date
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01/31/2007 |
Product Code |
LOB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR RELOCATING CABOT'S LAMICEL PROCESSING EQUIPMENT AND THE ASSOCIATED METHODS OR PROCEDURESTO THE MEROCEL FACILITY AT 950 FLANDERS ROAD, MYSTIC, CONNECTICUT, 06355 |
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