Pacemaker 208S

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K770005 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lead Modification

  Class III

  FDA 510(k) K770135 Active Cleared 7 Feb 1977

• Pulse Generator Model 629

  Class III

  FDA 510(k) K790670 Active Cleared 27 Jun 1979

• Puck 90M

  Class II

  FDA 510(k) K903576 Active Cleared 4 Sep 1990

• Sep Programmer for Puck U & Ud Filmchang

  Class II

  FDA 510(k) K842903 Active Cleared 21 Aug 1984

• Pulse Generator Model 637

  Class III

  FDA 510(k) K790792 Active Cleared 12 Oct 1979

• Sep Programmer Sep-M/Single-Plane &

  Class II

  FDA 510(k) K840389 Active Cleared 21 Feb 1984

See all devices from Elema-Schonander, Inc. →

• What is the primary clinical purpose of the Pacemaker 208S, and how does it function in the body?

  The Pacemaker 208S is designed to treat patients with bradycardia or conduction disorders by delivering periodic electrical pulses to stimulate the heart when its natural rhythm is insufficient. It contains a power supply and electronic circuitry to regulate cardiac rhythm, ensuring consistent contractions when the heart’s intrinsic conduction system fails.

• Is the Pacemaker 208S intended for reuse, or is it meant to be implanted as a single-use device?

  The Pacemaker 208S is classified as a single-use device per its regulatory submission, meaning it is intended for one-time surgical implantation and should not be reused. This aligns with its sterile, pre-packaged presentation for clinical use.

• How is the Pacemaker 208S supplied, and what precautions should be taken during handling?

  The device is supplied as a sterile, pre-packaged unit, ensuring it meets surgical implantation standards. Since it is implanted under sterile conditions, healthcare professionals must adhere to aseptic techniques during handling to prevent contamination before or during the procedure.

• Are there any known restrictions on using the Pacemaker 208S in environments with MRI machines?

  The device data does not specify any MRI safety restrictions for the Pacemaker 208S, meaning it may not be explicitly labeled as MRI-compatible or unsafe. However, clinicians should consult the full labeling or manufacturer guidelines to confirm compatibility before exposing patients to MRI environments.

• What regulatory pathway was followed for the FDA clearance of the Pacemaker 208S, and which advisory committee reviewed it?

  The Pacemaker 208S received FDA clearance through a Traditional 510(k) pathway (K770005) under regulation 870.3610, with a decision of Substantially Equivalent (SESE). Its review was conducted by the Cardiovascular Device Advisory Committee (CV), reflecting its classification as an Implantable Pacemaker Pulse-Generator.