polynovo tnp page

Ok, I just went ferreting around searching on Polynovo for news and noticed that someone from Calzada had been playing with the Polynovo site today. So I went to the TNP page.

The site now talks like TNP is approved for 510(k). Maybe jumping the gun?

http://polynovo.com/novosorb/products/topical-negative-pressure/

On the PolyNovo site it currently says

The 510(k) clearance allows NovoSorb™ to be used in several large markets, including the treatment of;

Acute surgical wounds,
Diabetic Foot Ulcers,
Pressure Ulcers,
Orthopaedic Trauma Wounds,
Dehisced wounds,
Other Chronic Ulcers and complex wounds.

No mention of in application or evaluation nor when it is likely to be complete. Just talks like its done.

I dont have a previous page obviously so cant compare to one earlier but its an interesting wording.