ActaStim-S Spine Fusion Stimulator

FDA Premarket Approval P190030 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

DeviceActaStim-S Spine Fusion Stimulator
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantTheragen, Inc.11220 Assett Loopsuite 101manassas, VA 20109 PMA NumberP190030 Supplement NumberS001 Date Received04/08/2022 Decision Date06/17/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-08
Decision Date2022-06-17
PMAP190030
SupplementS001
Product CodeLOF 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressTheragen, Inc.
11220 Assett Loop
suite 101
manassas, VA 20109 PMA NumberP190030 Supplement NumberS001 Date Received04/08/2022 Decision Date06/17/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Modifications To The Device Battery Charger.

Supplemental Filings

Supplement NumberDateSupplement Type
P190030Original Filing
S001 2022-04-08 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00850372007264 P190030 000
00850372007172 P190030 000
00850372007189 P190030 000
00850372007196 P190030 000
00850372007202 P190030 000
00850372007219 P190030 000
00850372007226 P190030 000
00850372007233 P190030 000
00850372007240 P190030 000
00850372007257 P190030 000
00850372007165 P190030 000

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