PRIMA PLUS STENTLESS BIOPROSTHESIS
FDA premarket approval P000007/S001 · decided 2002-02-12
Approval details
- PMA number
- P000007
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PRIMA PLUS STENTLESS BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2001-04-27
- Decision date
- 2002-02-12
- Days to decision
- 291 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL TO ADDRESS THE ISSUE OF LONG-TERM CLINICAL EFFECTIVENESS OF THE EDWARDS XENOLOGIX ANTICALCIFICATION TREATMENT AS STIPULATED IN THE FEBRUARY 27, 2001 APPROVAL ORDER.
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