Powerflex™ Pectoral Implant, Smooth (Aiache Style 4)

Basic Information

• Brand Name: Powerflex™ Pectoral Implant, Smooth (Aiache Style 4)
• Primary DI: M724ACPI4S3R1
• Version / Model: Size3, Right
• Catalog Number: ACPI4-S-3R
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Labeler DUNS: 784664955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 1ff59237-65e2-4bfc-b012-af36233e5fa8

Device Description

Pectoral Implant

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• 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
MIC	Implant, Muscle, Pectoralis	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48163	Pectoral implant	An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M724ACPI4S3R1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K944163	000