The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752. Naval Medical Logistics Command (NMLC) has a requirement for left atrial appendage closure (LAAC) devices for the NMC San Diego. The devices shall be able to be permanently implanted into the left atrial appendage of the heart to prevent blood clots from entering the bloodstream. The LAAC devices shall be able to be implanted via a catheter entering the body through a vein in the leg. Implantation of the device shall not require open heart surgery.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The devices shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA, with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

This notice of intent is not a request for competitive proposals; however, if a vendor challenges the basis of this requirement, please email challenges and product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Jayme L. Fletcher at [email protected], reference solicitation number N62645-16-T-0039. Closing date for challenges is no later than 1300 Local Time, 22 August 2016. No phone calls will be accepted. Please note that a determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

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