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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceLAMICEL OSMOTIC CERVICAL DILATOR
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
ApplicantMedtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville, FL 32216
PMA NumberP820075
Supplement NumberS008
Date Received06/24/1999
Decision Date07/09/1999
Withdrawal Date01/31/2007
Product Code LOB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-Day Notice requested a change in the approved sterilization process of e-beam to gamma radiation process.
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