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Please click on this link to view the FDA announcement regarding the 510(k) clearance of CryoValve SG.

Elkins RC et al. Decellularized human valve allografts, Ann Thorac Surg2001 May;71(5 Suppl):S428-32

Hawkins JA, et al. Immunogenicity of decellularized cryopreserved allografts in pediatric cardiac surgery: comparison with standard cryopreserved allografts. J Thorac Cardiovasc Surg2003 Jul;126(1):247-52; discussion 252-3

Tavakkol Z, et al. Superior durability of SynerGraft pulmonary allografts compared with standard cryopreserved allografts. Ann Thorac Surg 2005 Nov;80(5):1610-4
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