OMNISCEINCE PROSTHETIC CARDIAC VALVE
FDA premarket approval P830039 · decided 1985-05-03
Approval details
- PMA number
- P830039
- Trade name
- OMNISCEINCE PROSTHETIC CARDIAC VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medical Cv, Inc.
- Date received
- 1983-07-07
- Decision date
- 1985-05-03
- Days to decision
- 666 days
- Decision code
- APWD
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inver Grove Heights, MN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |