PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
FDA premarket approval P860057/S022 · decided 2004-01-26
Approval details
- PMA number
- P860057
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2003-06-20
- Decision date
- 2004-01-26
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF A POST-FIXATION TISSUE HEAT TREATMENT STEP IN GLUTARALDEHYDE SOLUTION PRIOR TO THE EDWARDS XENOLOGIX TISSUE VALVE PROCESSING STEPS. THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE REFERENCE TO THERMAFIX AS THE TRADEMARK/BRAND NAME FOR THE TISSUE PROCESSING METHOD AND WILL BE IDENTIFIED ACCORDING TO THE FOLLOWING MODIFIED MODEL NUMBERS: MODELS 2700TFX, 2800TFX, 6900PTFX, AND 3000TFX.
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