PMA P830039S009

Device: OMNISCIENCE CARDIAC VALVE PROSTHESIS
Applicant: Medical Cv, Inc.
PMA number: P830039
Supplement: S009
Product code: LWQ
Decision date: 1998-12-30
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: 1. MIXTURE OF STERILANT GAS FOR THE ETHYLENE OXIDE GAS NOW USED 2. A CHANGE IN THE VEHICLE FOR THE BACILLUS SUBTILIS VAR. NIGER BIOLOGICAL INDICATOR SAMPLES USED FOR STERILITY 3. REDUCTION OF THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS

Current openFDA PMA Record#

Device: OMNISCIENCE CARDIAC VALVE PROSTHESIS
Applicant: Medical Cv, Inc.
PMA number: P830039
Supplement: S009
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 1998-12-30
Decision code: OK30
Date received: 1998-12-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 1. MIXTURE OF STERILANT GAS FOR THE ETHYLENE OXIDE GAS NOW USED 2. A CHANGE IN THE VEHICLE FOR THE BACILLUS SUBTILIS VAR. NIGER BIOLOGICAL INDICATOR SAMPLES USED FOR STERILITY 3. REDUCTION OF THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS