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 | MODEL MFL5000 EXPANSION OF INDICATION RANGE |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | Dornier MedTech America, Inc. 1155 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P840008 |
Supplement Number | S040 |
Date Received | 05/11/1992 |
Decision Date | 03/08/1993 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Docket Number | 93M-0124 |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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