CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Intended Use: The Merlin® PSA is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting.
Only use the Merlin PSA with the Merlin PCS.
Contraindications: There are no known contraindications to the use of a lead-analysis device. The patient’s age and medical condition, however, may dictate the pacing modes and lead assessment activities appropriate for the patient.
The Merlin PSA is not intended for use as a temporary pacemaker or for life sustaining pacing support.
The Merlin PSA is not intended for diagnostic purposes.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
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