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 | OMNISENSE 7000S ULTRASOUND BONE SONOMETER |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | BEAM-MED LTD 8 HALAPID STR. PETACH TIKVA 49170 |
PMA Number | P990035 |
Supplement Number | S005 |
Date Received | 12/21/2001 |
Decision Date | 11/17/2003 |
Reclassified Date
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08/18/2008 |
Product Code |
MUA |
Advisory Committee |
Radiology |
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 A MANUFACTURING SITE LOCATED AT ZICON LTD., PETAH-TIKVA, ISRAEL. |
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