Prolaryn Plus Injectable Implant

Basic Information

• Brand Name: Prolaryn Plus Injectable Implant
• Primary DI: M2138044M0K55
• Version / Model: 8044M0K5
• Company Name: MERZ NORTH AMERICA, INC.
• Labeler DUNS: 028147846
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a5cc15b6-457e-4004-acf3-a9118a42ceca

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIX	System, Vocal Cord Medialization	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42516	Injectable vocal cord medialization implant, synthetic	An 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M2138044M0K55	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013243	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1.0	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 90 Degrees Fahrenheit