FDA.reportPublic FDA data

PASCAL

Primary DI
00690103216943
Brand
PASCAL
Company
Edwards Lifesciences LLC
Model
20000IS
Catalog number
20000ISA
Device description
PASCAL PRECISION SYSTEM – IMPLANT SYSTEM
Published
2022-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKMMitral Valve Repair Devices
NPSTricuspid Valve Repair Device, Percutaneously Delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKMMitral Valve Repair DevicesUnknown3
NPSTricuspid Valve Repair Device, Percutaneously DeliveredUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220003000PASCAL Precision Transcatheter Valve Repair SystemEdwards Lifesciences, LLC2022-09-14NKM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103216943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103216943006901032169436901032169430690103216943

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103222456AUTUS Size Adjustable ValveAUT001AUT0012026-10-30
00690103220636ESHEATH OPTIMA14000ES16A14000ES162025-10-09
00690103219784Edwards 23F Guide Sheath9880GS9880GSA2026-01-30
00690103219562Edwards EVOQUE Loading System9850LSB9850LSBUS2025-07-09
00690103219579Edwards EVOQUE Stabilizer9850SZUS9850SZUS2025-07-09
00690103220629ESHEATH OPTIMA INTRODUCER SET (14F)14000ES1414000ES142025-05-07
00690103217773Edwards EVOQUE Loading System9850LSAUS9850LSAUS2024-10-03
00690103217483EVOQUE9850PTUS9850PTUS2024-02-07
00690103217490EVOQUE9850LSUS9850LSUS2024-02-07
00690103217506EVOQUE9850DKUS9850DKUS2024-02-07
00690103217513EVOQUE9850SBUS9850SBUS2024-02-07
00690103217476EVOQUE9850BAUS9850BAUS2024-02-06
00690103215465Edwards eSheath+ Introducer set914ESP914ESPA2021-10-06
00690103215472Edwards eSheath+ Introducer set916ESP916ESPA2021-10-06
00690103182262EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T262015-09-24
00690103182279EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T282015-09-24
00690103182286EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T302015-09-24
00690103182293EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T322015-09-24
00690103182309EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T342015-09-24
00690103182316EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T362015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103222135PASCAL PrecisionEdwards Lifesciences LLCNKM2026-10-22
00690103222135PASCAL PrecisionEdwards Lifesciences LLCNPS2026-10-22
00690103221664PASCAL Ace with Capture Clarity Valve Repair SystemEdwards Lifesciences LLCNKM2026-09-24
00690103222388PASCAL PrecisionEdwards Lifesciences LLCNKM2026-09-24
00690103222388PASCAL PrecisionEdwards Lifesciences LLCNPS2026-09-24
05415067050717MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067050731TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067050748MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067050762MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067050779MitraClip™ST. JUDE MEDICAL, INC.NKM2025-12-11
05415067050816TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067050847TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067050885TriClip™ST. JUDE MEDICAL, INC.NPS2025-12-11
05415067047700TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12
05415067047724TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12
05415067047731TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12
05415067047755TriClip™ST. JUDE MEDICAL, INC.NPS2024-04-12
05415067037367MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
05415067037381MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
05415067037404MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
05415067037435MitraClip™ST. JUDE MEDICAL, INC.NKM2022-09-20
00690103216950PASCALEdwards Lifesciences LLCNKM2022-09-19
00690103216967PASCAL PRECISIONEdwards Lifesciences LLCNKM2022-09-19
00690103216967PASCAL PRECISIONEdwards Lifesciences LLCNPS2022-09-19
00690103216974PASCALEdwards Lifesciences LLCNKM2022-09-19
00690103216981PASCALEdwards Lifesciences LLCNKM2022-09-19
08717648230943MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648230967MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648230981MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11
08717648231001MITRACLIPABBOTT VASCULAR INC.NKM2019-11-11