Hancock Modified Orifice Bioprosthesis

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

heart-valve, non-allograft tissue

PMA Number

P790007 ↗

FDA Product Code

LWR

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S007

• Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore

  Class II

  FDA 510(k) K032810 Active Cleared 5 Dec 2003

• Cg Future Annuloplasty Band

  Class II

  FDA 510(k) K052860 Active Cleared 10 Nov 2005

• Simplici-T Annuloplasty System

  Class II

  FDA 510(k) K052970 Active Cleared 11 Jan 2006

• What type of device is the Hancock Modified Orifice Bioprosthesis?

  The Hancock Modified Orifice Bioprosthesis is a heart-valve, non-allograft tissue device, as defined in the specifications under generic_name and openfda device_name.

• Who manufactures the Hancock Modified Orifice Bioprosthesis?

  The device is manufactured by Medtronic Heart Valves, as stated in both the MANUFACTURER and applicant fields in the device data.

• What regulatory authorization does the Hancock Modified Orifice Bioprosthesis have?

  The device has FDA PMA authorization, with PMA number P790007 and decision date March 6, 1980, as shown in the AUTHORIZATIONS and pma_number fields.