OMNISENSE 7000S ULTRASOUND BONE SONOMETER

Bone Sonometer

FDA Premarket Approval P990035 S005

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 site located at zicon ltd. , petah-tikva, israel.

• Device: OMNISENSE 7000S ULTRASOUND BONE SONOMETER
• Classification Name: Bone Sonometer
• Generic Name: Bone Sonometer
• Applicant: BEAM-MED LTD
• Date Received: 2001-12-21
• Decision Date: 2003-11-17
• PMA: P990035
• Supplement: S005
• Product Code: MUA
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: BEAM-MED LTD 8 Halapid Str. petach Tikva 49170

Supplemental Filings

Supplement Number	Date	Supplement Type
P990035		Original 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 ID	PMA	Supp
07299012704119	P990035	000