PMA P830039S006

Device: OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE
Applicant: Medical Cv, Inc.
PMA number: P830039
Supplement: S006
Product code: LWQ
Decision date: 1997-03-26
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM THREE YEARS TO TEN YEARS AFTER THE INITIAL STERILIZATION OF THE OMNISCIENCE VALVE.

Current openFDA PMA Record#

Device: OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE
Applicant: Medical Cv, Inc.
PMA number: P830039
Supplement: S006
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 1997-03-26
Decision code: APPR
Date received: 1996-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM THREE YEARS TO TEN YEARS AFTER THE INITIAL STERILIZATION OF THE OMNISCIENCE VALVE.