Intermedics, Inc.

United StatesFDA applicant, unverified

Devices: 211

What Intermedics, Inc. makes

Intermedics, Inc. manufactures cardiac pacing components, including unipolar and bipolar pacing leads (e.g., Model 480-01, Poly Flex implantable pacing lead), implantable pulse generators, lead adapters (e.g., GE Lead Adapter Model 345-01, Adaptaid Lead Adapter #365-17), and header plugs (e.g., Model 366-15 VS 1). The company also produces tools like a syringe driver (MS-16) and a lensometer (Veri-Vu), as well as splicing crimps and sleeves for implant aids. Their product line covers both external and implanted cardiac devices, with a focus on pacing systems and related accessories.

The company’s devices are classified under FDA categories Class I, Class II, and Class III, with submissions recorded in the FDA 510(k) registry. These products are listed under U.S. regulatory oversight, and the company is headquartered in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue211

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What Intermedics, Inc. makes

Catalogue211

Silicone Rubber Isolation Sleeve 350-01 Ref K833199

Lifeline Endocardial Pacing Lead #479-05 Ref K830782

Polyflex Implantable Pacing Lead Ref K802293

Lifeline Endocardial Unipolar Lead 483-08 Ref K853517

Lifeline Tle 484-02 Ref K843394

8mm Quantum Pulse/Suprima Ii Pulse Generators Ref K911122

Cyberlith I Pulse Generator Model 253-04 Ref K810385

Model 366-27 Adaptaid(Tm) Step-Down Adapter Ref K864048

Adaptaid #365-38 Ref K812756

Model 253-11 Cyberlith Pulse Generator Ref K800895

Model 484-01 Bipolar Coaxial Pacing Lead Ref K791377

Adaptaid Lead Adapter #365-25 Ref K811938

Model 430-07 Endocardial Pacing Lead Ref K954610

Model 435-01 Cardifix Implantable Pacing Lead Ref K854917

Intermedics Poly Flex Epicardial Suture Ref K812221

Adaptaid(Tm) Adapter Sleeve Model 366-33 Ref K894718

Intermedics Polyflex-Model 483-03 Lead Ref K812990

Rate Programmer Model 520 Ref K780175

Intermedics Model 431-11 Implant Endocard Pac Lead Ref K903948

Model 366-08 Adaptaid Connector Adapter Ref K860832

Biplr Im En Pac Leads (430-07, 432-03, 436-02 & 07, 438-05 & 07) Ref K962174

Model 483-01 Pacing Lead Ref K844262

Model 476-03 Pacing Lead Ref K844260

Implantable Pulse Generator Pacemaker Ref K791417

Model 535-03 Trace A Pace Ref K812755

Model 366-28 Adaptaid(Tm) Step-Down Adapter Ref K864047

Model 486-01 Pacing Lead Ref K844259

Model 483-01 Pacing Lead Ref K844267

Implantable Pulse Generator Ref K834096

Intermedics' Lifeline Tle Endocardial Ref K801172

Intermedics Cyberlith I Biopolar Cardi Ref K810383

#335-01 Silic Rub Isola Sleeve For Int #281-03 Siz Ref K853034

Model 492-03 Polyflex Implantable Pacing Lead Ref K853410

Model 437-01 Biopore Implantable Pacing Lead Ref K862258

Model 483-06 Polyflex Implantable Pacing Lead Ref K851457

Model 352-01 Silicone Rubber Isolation Sleeve Ref K863418

Adaptaid Temp. Pacing Ext. Lead #366-02 Ref K820268

Model 435-04 Cardifix Side Hook Implant. Pace Lead Ref K875178

Model 433-01 Biopore Implantable Pacing Lead Ref K862259

Model 493-08 Polyflex Endocardial Lead Ref K863781

Model 439-07 And 439-09 Lifeline Myocardial Lead Ref K880551

Intermedics Poly Flex Endocardial Pacing Ref K811106

Model 490-01 Pacing Lead Ref K844261

Biopore VS.1 Endocardial Inter Implant Pacing Lead Ref K883602

Intermedics Cyberlith Bipolar Cardiac Ref K811221

Insulative Coating For Card. Pulse Gen Ref K810901

Model 366-12 Adaptaid(Tm) Step-Down Adapter Ref K874930

Model 479-01 Pacing Lead Ref K844271

Cardifix Endocardial Pacing Lead Ref K922042

Interceptor, 662-01 Ref K844279