PMA P900060S019

Device: SULZER CARBOMEDICS CPHV OPTIFORM VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S019
Product code: LWQ
Decision date: 1999-06-01
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name CPHV(TM) OptiForm(TM) Valve and will be available in the following model numbers and sizes: Aortic Model F500 (sizes 19, 21, 23, 25, 27, 29, and 31 mm), and Mitral Model F700 (sizes 21, 23, 25, 27, 29, 31, and 33 mm). The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.

Current openFDA PMA Record#

Device: SULZER CARBOMEDICS CPHV OPTIFORM VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S019
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 1999-06-01
Decision code: APPR
Date received: 1999-05-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name CPHV(TM) OptiForm(TM) Valve and will be available in the following model numbers and sizes: Aortic Model F500 (sizes 19, 21, 23, 25, 27, 29, and 31 mm), and Mitral Model F700 (sizes 21, 23, 25, 27, 29, 31, and 33 mm). The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.