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 | DILAPAN(TM) |
Generic Name | dilator, cervical, synthetic, osmotic, pregnancy termination |
Applicant | MEDICEM TECHNOLOGY S.R.O KARLOVARSHA TRIDA 20 KAMENNE ZEHROVICE 27301 |
PMA Number | P840045 |
Supplement Number | S002 |
Date Received | 08/04/1987 |
Decision Date | 09/28/1988 |
Withdrawal Date
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06/15/2015 |
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 |
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