FDA.reportPublic FDA data

Solesta®

Primary DI
00365649850035
Brand
Solesta®
Company
SALIX PHARMACEUTICALS, LTD.
Model
1085003
Device description
SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
Published
2014-10-31
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
LNMAgent, Bulking, Injectable For Gastro-Urology Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNMAgent, Bulking, Injectable For Gastro-Urology UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100014014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100014014SOLESTA INJECTABLE GELPalette Life Sciences2011-05-27LNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10365649850032PackageGS132In Commercial Distribution
00365649850035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036564985003210365649850032
00365649850035003656498500353656498500350365649850035

GMDN Terms#

Term, Definition table
TermDefinition
Anal tissue reconstructive materialA sterile, bioabsorbable substance intended for submucosal injection in the anal canal to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of faecal incontinence; it does not include a local anaesthetic agent. It is in the form of a gel of biosynthesized dextranomer microspheres and hyaluronic acid (HA) derived from bacteria. The material is typically preloaded in a disposable syringe. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005080024salix@medcomsol.com

Regulatory Flags#

DUNS number
793108036
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365649922039Deflux®10922032014-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810235030645CoaptiteMERZ NORTH AMERICA, INC.LNM2024-10-15
10810005340509BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-09-12
10810005340493BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-08-30
05704101500500BulkamidContura International A/SLNM2020-03-10
00850004725023Deflux Metal NeedlePALETTE LIFE SCIENCES, INC.LNM2019-02-11
00850004725009DefluxPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00850004725016SolestaPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00365649922039Deflux®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
08714729804796CoaptiteMERZ NORTH AMERICA, INC.LNM2014-09-17
00858015005004Durasphere ® EXP Carbon Medical Technologies, Inc.LNM2014-09-17
00858015005011Durasphere ® EXPCarbon Medical Technologies, Inc.LNM2014-09-17
08717591240266Macroplastique ImplantsUroplasty, Inc.LNM2014-06-20