Latest From FzioMed Inc.
With more data submitted to CDRH, FzioMed and the device center have agreed to postpone a planned June 10 dispute-resolution panel meeting on the firm’s previously rejected PMA for the Oxiplex spine surgery gel.
FDA has officially scheduled the first meeting of its Medical Devices Dispute Resolution Panel in more than seven years to assess the case of FzioMed Inc.’s PMA for the Oxiplex gel for lumbar spine surgery. An ophthalmic devices panel has been set for a new corneal implant, and more regulatory news.
FDA releases draft guidance on human leukocyte antigen test kits. Wright Medical announces its Augment bone graft will go to FDA’s Dispute Resolution Panel. More news.
FDA granted FzioMed’s petition for an independent review of its Oxiplex gel PMA by the Medical Devices Dispute Resolution Panel in response to FzioMed’s November 2012 petition. The agency deemed the device, intended for use in spine surgery, as “not approvable” in 2008.
- Drug Delivery
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- FzioMed Inc.
- Senior Management
Ronald F Haynes, Pres. & CFO
John M Blackmore, VP, Mktg. & Bus. Dev.
Ronald J Ehmsen, VP, Clinical Affairs
- Contact Info
Phone: (805) 546-0610
170-A Granada Drive
San Luis Obispo, CA 93401
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