CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
FDA premarket approval P870077 · decided 1991-09-25
Approval details
- PMA number
- P870077
- Trade name
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 1987-12-07
- Decision date
- 1991-09-25
- Days to decision
- 1388 days
- Decision code
- APWD
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the Carpentier-Edwards® Duraflex Bioprosthesis, Models 6625 LP and 6625-ESR-LP. These devices are intended for use in patients whose mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted mitral valve prosthesis which is no longer functioning adequately and requires replacement.
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