FDA.reportPublic FDA data

Altis

Primary DI
05708932467407
Brand
Altis
Company
Coloplast A/S
Model
519650
Catalog number
519650
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAHmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121562000
K221874000
K242473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121562000ALTIS SINGLE INCISION CLING SYSTEMColoplast A/S2012-11-05PAH
K221874000Altis Single Incision Sling SystemColoplast A/S2023-02-15PAH
K242473000Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp.2024-10-18PAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932467407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932467407057089324674075708932467407

GMDN Terms#

Term, Definition table
TermDefinition
Stress urinary incontinence surgical mesh, femaleA sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, Specify00Keep out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437007606058Needleless SlingDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLPAH2020-10-19
00890594000957Desara One Caldera Medical, Inc.PAH2020-02-25
00890594000971Desara One Caldera Medical, Inc.PAH2020-02-25
08714729961901Solyx™ BlueBOSTON SCIENTIFIC CORPORATIONPAH2018-06-13
28032919892120T-SLINGHERNIAMESH SRLPAH2016-08-05
00814723020036MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020104MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020364MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
08714729774044Solyx™ SIS SystemBOSTON SCIENTIFIC CORPORATIONPAH2015-09-24
08714729784784Solyx™ SIS System BOSTON SCIENTIFIC CORPORATIONPAH2015-09-24