Data / Medical devices / Singapore / EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd
EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd: FDA-registered device maker in Changi South East, Singapore, 8 PMA approvals
EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd is registered with the FDA (registration 3007063218) in Changi South East, Singapore. It lists 8 device types. The FDA files 8 PMA approvals under its listings, the newest dated February 1, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007063218
- Address
- 35 Changi North Crescent, Changi South East, Singapore, 499641
- Owner or operator
- Edwards Lifesciences LLC (9040666)
- Roles
- Manufacturer
- First device listed
- January 17, 2008
- Registered through
- 2027
- Brand names listed
- Ascendra + Introducer Sheath Set, Ascendra+ Delivery System, Ascendra+ System, Carpentier-Edwards Perimount Bioprosthesis, Crimp Stopper, EDWARDS INTUITY Elite Valve System, EVOQUE, EVOQUE tricuspid delivery system, dilator kit, and loading system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | 3 | Manufacturer | accessdata.fda.gov |
| Heart-Valve, Non-Allograft Tissue | LWR | 3 | Manufacturer | accessdata.fda.gov |
| Mitral Valve Repair Devices | NKM | 3 | Manufacturer | accessdata.fda.gov |
| Percutaneously Delivered Prostheses And Tricuspid Valves | NPW | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Mitral Valve, Percutaneously Delivered | NPU | 3 | Manufacturer | accessdata.fda.gov |
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | f | Manufacturer | accessdata.fda.gov |
| Replacement Heart-Valve | DYE | 3 | Manufacturer | accessdata.fda.gov |
| Tricuspid Valve Repair Device, Percutaneously Delivered | NPS | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 1, 2024 | P230013 | Edwards EVOQUE Tricuspid Valve Replacement System | NPW | 32 | October 21, 2026 | accessdata.fda.gov |
| September 14, 2022 | P220003 | PASCAL Precision Transcatheter Valve Repair System | NKM | 33 | October 22, 2026 | accessdata.fda.gov |
| August 31, 2020 | P200015 | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | NPV | 80 | September 23, 2026 | accessdata.fda.gov |
| June 29, 2017 | P150048 | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) | LWR | 97 | October 22, 2026 | accessdata.fda.gov |
| August 12, 2016 | P150036 | EDWARDS INTUITY ELITE VALVE SYSTEM | LWR | 77 | July 29, 2026 | accessdata.fda.gov |
| June 17, 2015 | P140031 | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | NPT | 202 | October 22, 2026 | accessdata.fda.gov |
| June 16, 2014 | P130009 | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | NPT | 101 | March 19, 2021 | accessdata.fda.gov |
| September 26, 1991 | P860057 | EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES | DYE | 210 | July 29, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Pulmonary Valve Prosthesis Percutaneously Delivered
- All makers of Mitral Valve Repair Devices
- All makers of Tricuspid Valve Repair Device, Percutaneously Delivered
- All makers of Heart-Valve, Non-Allograft Tissue
- All makers of Percutaneously Delivered Prostheses And Tricuspid Valves
- All makers of Aortic Valve, Prosthesis, Percutaneously Delivered
Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.