EDWARDS INTUITY VALVE SYSTEM
FDA premarket approval P150036/S001 · decided 2017-05-01
Approval details
- PMA number
- P150036
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EDWARDS INTUITY VALVE SYSTEM
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2016-11-15
- Decision date
- 2017-05-01
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the addition of the Edwards Singapore facility for manufacturing components used in Edwards surgical and transcatheter heart valves.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| 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 |