FDA.reportPublic FDA data

ALLURA®

Primary DI
00650551002932
Brand
ALLURA®
Company
PMT CORPORATION
Model
3321-214-T
Device description
VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X14CM, 4CM PROJECTION, 140CC FILL
Published
2025-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXPStent, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXPStent, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202542000Allura Vaginal StentPmt Corporation2020-09-30KXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551002932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551002932006505510029326505510029320650551002932

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric vaginal stent, non-bioabsorbableA sterile non-bioabsorbable tubular device intended for long-term placement in the vagina to provide structural support and/or prevent shrinking. It is typically used for vaginal dilation following surgical or non-surgical treatment of vaginal agenesis or transgender vaginoplasty, or for the prevention of vaginal contracture or stenosis after radiotherapy. It is made of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., inflatable tubular envelope with valves and internal drains, semi-soft moulded tube). This is a single-patient use device that can be reapplied to the patient during the treatment period (e.g., nightly) before being discarded (reusable).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006978PMT® SUCTION INSTRUMENTS9002-07-100-ST2026-07-20
00650551006992CORTAC®2110-08-1452026-07-20
00650551006794ILSO™1515-08SF2026-07-18
00650551006800ILSO™1515-08MF2026-07-17
00650551006817ILSO™1515-08LF2026-07-17
00650551006824ILSO™1515-08XF2026-07-17
00650551006831ILSO™1515-08SM2026-07-17
00650551006848ILSO™1515-08MM2026-07-17
00650551006855ILSO™1515-08LM2026-07-17
00650551006862ILSO™1515-08XM2026-07-17
00650551006879ITLSO™1535-08SF2026-07-17
00650551006886ITLSO™1535-08MF2026-07-17
00650551006893ITLSO™1535-08LF2026-07-17
00650551006909ITLSO™1535-08XF2026-07-17
00650551006916ITLSO™1535-08SM2026-07-17
00650551006923ITLSO™1535-08MM2026-07-17
00650551006930ITLSO™1535-08LM2026-07-17
00650551006947ITLSO™1535-08XM2026-07-17
00650551006954ILSO™1515-08CUSTOM2026-07-17
00650551006961ITLSO™1535-08CUSTOM2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551003229ALLURA®PMT CORPORATIONKXP2025-03-19
00650551003236ALLURA®PMT CORPORATIONKXP2025-03-19
00650551003458ALLURA®PMT CORPORATIONKXP2025-03-19
00650551005148ALLURA®PMT CORPORATIONKXP2025-03-19
00650551147619ALLURA®PMT CORPORATIONKXP2025-03-19
00650551002758ALLURAPMT CORPORATIONKXP2021-10-27
00650551002222ALLURAPMT CORPORATIONKXP2021-09-20
00650551002239ALLURAPMT CORPORATIONKXP2021-09-20
00650551002246ALLURAPMT CORPORATIONKXP2021-09-20
00650551002253ALLURAPMT CORPORATIONKXP2021-09-20
00650551002260ALLURAPMT CORPORATIONKXP2021-09-20
00650551002277ALLURAPMT CORPORATIONKXP2021-09-20
00650551002284ALLURAPMT CORPORATIONKXP2021-09-20
00650551002666ALLURAPMT CORPORATIONKXP2021-09-20
00384702171016Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702172013Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702173010Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702174017AmielleOWEN MUMFORD LIMITEDKXP2016-09-22
00384702178015Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702179012Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702190017AmielleOWEN MUMFORD LIMITEDKXP2016-09-22
00384702100016AmielleOWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702100030AmielleOWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702101013Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702102010Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702103017Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702104014Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702105011Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00812790024919SIENTRA Vaginal StentSientra, Inc.KXP2015-10-23
00812790024926SIENTRA Vaginal StentSientra, Inc.KXP2015-10-23