EMS-SWISS DOLORCLAST

FDA Premarket Approval P050004 S001

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 e. M. S. Electro medical systems, sa, nyon, switzerland.

DeviceEMS-SWISS DOLORCLAST
Generic NameGenerator, Shock-wave, For Pain Relief
ApplicantELECTRO MEDICAL SYSTEMS (EMS SA)
Date Received2009-02-25
Decision Date2009-08-28
PMAP050004
SupplementS001
Product CodeNBN 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ELECTRO MEDICAL SYSTEMS (EMS SA) ch. De La Vuarpilliere 31 nyon, Vaud CH-12-1260

Supplemental Filings

Supplement NumberDateSupplement Type
P050004Original Filing
S001 2009-02-25 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
07613353194895 P050004 000
07613353077464 P050004 001
07613353170264 P050004 001
07613353181284 P050004 001
07613353000011 P050004 001
07613353000028 P050004 001
07613353000035 P050004 001
07613353000042 P050004 001
07613353000059 P050004 001
07613353000066 P050004 001
04260153472031 P050004 001
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