OMNISCIENCE AND OMNICARBON CARDIAC VALVES
FDA premarket approval P830039/S008 · decided 1998-09-25
Approval details
- PMA number
- P830039
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OMNISCIENCE AND OMNICARBON CARDIAC VALVES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medical Cv, Inc.
- Date received
- 1998-07-22
- Decision date
- 1998-09-25
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inver Grove Heights, MN
- Statement
- Approval for modifications to various cleaning methods utilized during production of the Omniscience(R) valve to remove chlorofluorocarbon solvents.
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|---|---|---|
| ATRILAZE LASER ABLATION SYSTEM (K081457) | Medical Cv, Inc. | 2008-08-08 |
| ATRILAZE MI SURGICAL ABLATION SYSTEM (K061489) | Medical Cv, Inc. | 2007-03-16 |
| ATRILAZE SURGICAL ABLATION SYSTEM (K060680) | Medical Cv, Inc. | 2006-04-11 |
| ATRILAZE MALLEABLE ABLATION PROBE (K052495) | Medical Cv, Inc. | 2005-10-11 |
| ATRILAZE SOFT TISSUE ABLATION SYSTEM (K040744) | Medical Cv, Inc. | 2004-11-30 |
| NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 (K033685) | Medical Cv, Inc. | 2004-08-03 |