Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial
FDA premarket approval P860057/S194 · decided 2019-11-24
Approval details
- PMA number
- P860057
- Supplement
- S194
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2019-11-01
- Decision date
- 2019-11-24
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- to down classify gowning room 129 from ISO Class 7 to ISO Class 8 at the Irvine facility
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
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| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |