Exhibit 99.3

[DEPARTMENT OF HEALTH & HUMAN SERVICES LETTERHEAD]

Mr. Peter Weiman
Healthtronics Surgical Services, Inc.
1841 West Oak Parkway, Suite A
Marietta, Georgia 30062

|Re: |  | P990086/S3
Healthtronics OssaTron®
Filed: November 5, 2001
|--- |  | ----------------------------------------------------------
|    |  | Amended:                                                  

Dear
Mr. Weiman:

The
Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for the Healthtronics
OssaTron®. The device is indicated for use for performing extracorporeal shock wave (ESW) treatment in patients with chronic lateral epicondylitis (tennis elbow) that has failed to respond
to conservative treatment. Chronic Lateral Epicondylitis is defined as lateral epicondylitis that has persisted for 6 months or more with a history of unsuccessful conservative treatment. The
PMA supplement is approved. You may begin commercial distribution of the device as modified in accordance with the conditions described below and in the "Conditions of Approval" (enclosed).

The
sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109 within the meaning of section 520(e) of the Federal Food, Drug, and Cosmetic
Act (the act) under the authority of section 515 (d)(1)(B)(ii) of the act. FDA has also determined that, to ensure the safe and effective use of the device, the device is further
restricted within the meaning of section 520(e) under the authority of section 515(d)(1)(B)(ii), (1) insofar as the labeling specify the requirements that apply to the training of
practitioners who may use the device as approved in this order and (2) insofar as the sale, distribution, and use must not violate sections 502(q) and (r) of the act.

CDRH
does not evaluate information related to contract liability warranties, however you should be aware that any such warranty statements must be truthful, accurate, and not misleading, and must be
consistent with applicable Federal and State laws.

CDRH
will notify the public of its decision to approve your PMA by making available a summary of the safety and effectiveness data upon which the approval is based. The information can be found on the
FDA CDRH Internet HomePage located at http://www.fda.gov/cdrh.pmapage.html. Written requests for this information can also be made to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is
placed on the Internet, any interested person may seek review of this decision by requesting an opportunity for administrative review, either through a hearing or review by an independent advisory
committee, under section 515(g) of the Federal Food, Drug, and Cosmetic Act (the act).

Failure
to comply with the conditions of approval invalidates this approval order. Commercial distribution of a device that is not in compliance with these conditions is a violation of the act.

You
are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with copies of all approved labeling affected by this
supplement in final printed form. The labeling will not routinely be reviewed by FDA staff when PMA supplement applicants include with their submission of the final printed labeling a cover letter
stating that the final printed labeling is identical to the labeling approved in draft form. If the final

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printed labeling is not identical, any changes from the final draft labeling should be highlighted and explained in the amendment.

All
required documents should be submitted in triplicate, unless otherwise specified, to the address below and should reference the above PMA number to facilitate processing.



If
you have any questions concerning this approval order, please contact Neil R. P. Ogden at (301) 594-1307.

| |  | Sincerely yours,                                                                                                                                                          
| |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| |  | /s/ Celia M. Witten, Ph.D., M.D.                                                                                                                                          
| |  | Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative
    and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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