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 | TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER |
Generic Name | Catheter, sampling, chorionic villus |
Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. KEENE, NH 03431 |
PMA Number | P890024 |
Supplement Number | S003 |
Date Received | 05/28/1991 |
Decision Date | 04/21/1992 |
Withdrawal Date
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03/10/2008 |
Product Code |
LLX |
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 |
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