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 | ECONOLITH(TM) LITHOTRIPTER |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | MEDISPEC, LTD. 19110 MONTGOMERY VILLAGE AVE. SUITE 100 MONTGOMERY VILLAGE, MD 20886 |
PMA Number | P950043 |
Supplement Number | S005 |
Date Received | 07/20/1998 |
Decision Date | 09/14/1998 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet T., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel. |
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