Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013973539

FEI Number

3013973539

Entity Name

FERMATEX VASCULAR TECHNOLOGIES D.B.A. ADAM SPENCE

City/State/Country

Wall, NJ, US

Establishment Address

1746 Route 34, Wall, NJ 07727, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Spectrum Plastics Group (Fermatex Vascular Tech D.B.A Adam S (Owner Number: 10084051)

Owner / Operator Contact Address

1746 Route 34, Wall, NJ 07727, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sitzmarks Sitzmarks Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2024-04-12
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2024-04-12
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2022-01-17

Official Correspondent

Grace Perez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spectrum Plastics Group (Fermatex Vascular Tech D.B.A Adam S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Similar Registrations

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3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3012302888	QUIPMENT INC.	Kennesaw, GA, US
2023374	DIVERSATEK HEALTHCARE INC.	Highlands Ranch, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013973539. Last updated year: 2026. Please use registration number 3013973539 when referencing this establishment in official correspondence.