OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE
FDA premarket approval P830039/S006 · decided 1997-03-26
Approval details
- PMA number
- P830039
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medical Cv, Inc.
- Date received
- 1996-09-30
- Decision date
- 1997-03-26
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inver Grove Heights, MN
- Statement
- APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM THREE YEARS TO TEN YEARS AFTER THE INITIAL STERILIZATION OF THE OMNISCIENCE VALVE.
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