PMA P830039S011

Device: OMNICARBON CARDIAC VALVE PROSTHESIS
Applicant: Medical Cv, Inc.
PMA number: P830039
Supplement: S011
Product code: LWQ
Decision date: 2002-10-29
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL FOR THE OMNICARBON CARDIAC VALVE PROSTHESIS IN THE ADDITIONAL SIZE OF 21 MM OF THE MODEL 3313 (AORTIC) AND SIZE 25 MM OF THE MODEL 3523 (MITRAL). THE SUPPLEMENT REQUESTED APPROVAL OF THESE SIZES AS AN ADDITION TO THE EXISTING, APPROVED (JULY 26, 2001; P830039/S007) PRODUCT LINE OF AORTIC SIZES 23, 25, 27 AND 29 MM, AND MITRAL SIZES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL VALVES.

Current openFDA PMA Record#

Device: OMNICARBON CARDIAC VALVE PROSTHESIS
Applicant: Medical Cv, Inc.
PMA number: P830039
Supplement: S011
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2002-10-29
Decision code: APPR
Date received: 2002-05-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE OMNICARBON CARDIAC VALVE PROSTHESIS IN THE ADDITIONAL SIZE OF 21 MM OF THE MODEL 3313 (AORTIC) AND SIZE 25 MM OF THE MODEL 3523 (MITRAL). THE SUPPLEMENT REQUESTED APPROVAL OF THESE SIZES AS AN ADDITION TO THE EXISTING, APPROVED (JULY 26, 2001; P830039/S007) PRODUCT LINE OF AORTIC SIZES 23, 25, 27 AND 29 MM, AND MITRAL SIZES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL VALVES.