FDA.reportPublic FDA data

Prolaryn Plus Injectable Implant

Primary DI
M2138044M0K55
Brand
Prolaryn Plus Injectable Implant
Company
MERZ NORTH AMERICA, INC.
Model
8044M0K5
Device description
Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle.
Published
2015-10-28
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
MIXSystem, Vocal Cord Medialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIXSystem, Vocal Cord MedializationEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013243000COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1Bioform, Inc.2002-01-09KHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2138044M0K55PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Injectable vocal cord medialization implant, syntheticAn implantable synthetic material [e.g., calcium hydroxyapatite, polytetrafluoroethylene (PTFE) -- commonly known as Teflon] designed as a space-occupying bulking agent to treat patients with unilateral vocal cord paralysis to improve voice quality. The device is typically available in a sterile syringe with needle, and is injected into the paralyzed vocal cord tissue, filling it and shifting it midline (vocal cord medialization). The properties of the device may facilitate ingrowth of the surrounding tissue over time. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit90 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
866-862-1211info@merz.com

Regulatory Flags#

DUNS number
028147846
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810235030860US Accessory Kit8070M02026-03-05
00810235030877US Rigid Needle with Support Cannula- Double Bevel9010M02026-03-05
00810235030884US Rigid Injection Needle with Huber Point9001M02026-03-05
00810235030846Prolaryn Gel 1.0 cc2026-02-24
00810235030853Prolaryn Plus1.0 cc2026-02-24
10810235030638"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"9012M02024-10-21
10810235030645Coaptite8005M02024-10-15
M2138700M05Belotero Balance8700M02014-09-17
M2139022M1X205"K-Pack II Needle 27 GA x 0.75"" T.W. (0,4 x 20mm)"9022M1X202022-12-08
08714729804796Coaptite8005P10M00689030002014-09-17
M2138063M0K15Radiesse (+) Lidocaine1.5cc Injectable Implant8063M0K12015-08-19
M2138063M0K25Radiesse (+) Lidocaine8063M0K22016-09-09
M2138067M0K15Radiesse (+) Lidocaine 0.8cc Injectable Implant8067M0K12015-08-19
M2138069M0K15Radiesse Moderate Fill 0.8cc8069M0K12014-09-17
M2138071C0K15Radiesse Volume Advantage 1.5cc8071C0K12016-03-30
M2138071M0H15Radiesse Injectable Implant1.5cc8071M0H12016-06-24
M2138071M0K15Radiesse Volume Advantage 1.5cc8071M0K12014-09-17
M2138071M0K25Radiesse Volume Advantage8071M0K22016-09-09
M2138602M0K55Prolaryn Gel Injectable Implant8602M0K52015-10-28
00186295000342DeScribe Transparent PFD Patch50358382017-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810235030846Prolaryn Gel MERZ NORTH AMERICA, INC.MIX2026-02-24
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