OMNISCEINCE PROSTHETIC CARDIAC VALVE
FDA premarket approval P830039/S002 · decided 1988-08-18
Approval details
- PMA number
- P830039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OMNISCEINCE PROSTHETIC CARDIAC VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medical Cv, Inc.
- Date received
- 1988-01-25
- Decision date
- 1988-08-18
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inver Grove Heights, MN
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| ATRILAZE LASER ABLATION SYSTEM (K081457) | Medical Cv, Inc. | 2008-08-08 |
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| 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 |
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