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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedilator, cervical, synthetic, osmotic, pregnancy termination
Generic Namecervical dilator
PMA NumberP820075
Supplement NumberS007
Date Received05/22/1995
Decision Date01/03/1996
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relocating cabot's lamicel processing equipment and the associated methods or procedures to the merocel facility at 950 flanders road, mystic, connecticut, 06355.