EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices, Annex II Section 4 Supplementary Information to CE 649387 Issued To: No. Issued To: Argon Medical Devices, Inc. CE 649387 1445 Flat Creek Road Argon Medical Devices, Inc. Athens 1445 Flat Texas Creek Road 75751 Athens USA Texas Option ELITE Vena Cava Filter System BSI has performed a design examination on the above devices in accordance with the Council Directive 93/42/EEC, Annex II Section 4. The design conforms to the requirements of this directive. For marketing of these products an additional Annex II excluding Section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797): Gary E Slack, Senior Vice President Medical Devices First First Issued: Issued: 2016-06-09 2016-06-09 Expiry Expiry Date: Date: 2024-02-16 2024-02-16 Page 1 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.

Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road Classification: class III Intended purpose per IFU The Option ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant...

Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2016-06-09 Date: 2020-04-16 Expiry Date: 2024-02-16 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands...