SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER

FDA Premarket Approval P990035 S002

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.

Pre-market Approval Supplement Details

Approval for a manufacturing facility located at sunlight medical ltd. , tel-aviv, israel.

DeviceSUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER
Generic NameBone Sonometer
ApplicantBEAM-MED LTD
Date Received2001-06-26
Decision Date2001-07-27
PMAP990035
SupplementS002
Product CodeMUA 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonExpress Gmp Supplement
Expedited ReviewNo
Combination Product No
Applicant Address BEAM-MED LTD 8 Halapid Str. petach Tikva 49170

Supplemental Filings

Supplement NumberDateSupplement Type
P990035Original Filing
S006 2002-11-01 Normal 180 Day Track
S005 2001-12-21 Normal 180 Day Track
S004 2001-09-25 Normal 180 Day Track
S003 2001-08-10 Normal 180 Day Track
S002 2001-06-26 Normal 180 Day Track
S001 2000-06-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07299012704119 P990035 000
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