LLD LEAD LOCKING DEVICE LLD #3 Box of 3

Important Safety Information Indications The Spectranetics Lead Locking Device, LLD, is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

Contrindications Use of the LLD is contraindicated:

• When emergency thoracotomy with cardiopulmonary bypass cannot be performed immediately in the event of a life-threatening complication.

• When fluoroscopy is not available.

• In patients in whom superior venous approach cannot be used.

• When the proximal end of the pacing lead is not accessible to the operator.

• When the LLD will not fit into the inner lumen of the device to be extracted.

Precautions:

For single use only. Do not resterilize and/or reuse.

The LLD is intended to be used in one lead.

Do not use the LLD: if the tamper-evident seal is broken; if the LLD has been damaged.

When the LLD is in the body, it should be manipulated only under fluoroscopic observation.

Due to rapidly evolving