Atlas FDA

PASCAL Precision Transcatheter Valve Repair System

FDA premarket approval P220003/S015 · decided 2024-04-15

Approval details

PMA number
P220003
Supplement
S015
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PASCAL Precision Transcatheter Valve Repair System
Generic name
Mitral valve repair devices
Applicant
Edwards Lifesciences, LLC
Date received
2023-10-19
Decision date
2024-04-15
Days to decision
179 days
Decision code
APPR
Product code
NKM
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for changes in suppliers from injection molding to commercial injection molding for various delivery system handle components, a new supplier for a machined handle component, addition of the Edwards logo to external-facing handle components, minor geometric modifications of the HDPE packaging card, and the implementation of a ultraviolet (UV) curing process for a specific bond in the Guide Sheath.

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

RecordFirmDate
Respiration Rate algorithm (K251326)Edwards Lifesciences, LLC2026-06-11
HemoSphere Nano Monitor (HSNANO1) (K253186)Edwards Lifesciences, LLC2026-02-24
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982)Edwards Lifesciences, LLC2025-09-23
Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
Hypertension Prediction Index (HePI) Algorithm (K242518)Edwards Lifesciences, LLC2025-05-15
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909)Edwards Lifesciences, LLC2025-03-21
Fogarty Thru-Lumen Embolectomy Catheter (K240078)Edwards Lifesciences, LLC2024-08-28
Acumen Assisted Fluid Management (AFM) Software Feature (K233984)Edwards Lifesciences, LLC2024-08-02