CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX
FDA premarket approval P860057/S040 · decided 2006-11-08
Approval details
- PMA number
- P860057
- Supplement
- S040
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2006-10-02
- Decision date
- 2006-11-08
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TRADE NAME CHANGE FOR THREE DEVICES, THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX, THE CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX, AND THE CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL MITRAL B
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