ActaStim-S Spine Fusion Stimulator

FDA Premarket Approval P190030

Pre-market Approval Supplement Details

The actastim-s spine fusion stimulator is a noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is rx only, and intended for single patient use in adult patients only.

DeviceActaStim-S Spine Fusion Stimulator
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantTheragen, Inc.
Date Received2019-11-18
Decision Date2020-12-09
PMAP190030
SupplementS
Product CodeLOF 
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Theragen, Inc. 11220 Assett Loop suite 101 manassas, VA 20109

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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