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RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER

FDA premarket approval P100041/S027 · decided 2013-05-22

Approval details

PMA number
P100041
Supplement
S027
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER
Generic name
Aortic valve, prosthesis, percutaneously delivered
Applicant
Edwards Lifesciences, LLC
Date received
2013-04-23
Decision date
2013-05-22
Days to decision
29 days
Decision code
APPR
Product code
NPT
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
APPROVAL FOR ADDITION OF POLYETHYLENE FOAM TO THE BASE OF THE CRIMPER DURING PACKAGING, A CHANGE TO THE CRIMPER PACKAGE RELEASE TEMPERATURE SET POINT, AND ADDITION OF POUCH INTEGRITY INSPECTIONS FOR ALL SAPIEN ACCESSORIES.

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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