480
Opinion of the Court
D. Sundwall, The Federal Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987) (55 § 510(k) notifications are filed for each PMA application; average FDA response to § 510(k) notification is one-fifth the response time to a PMA).4
II
As have so many other medical device manufacturers, petitioner Medtronic took advantage of § 510(k)'s expedited process in October 1982, when it notified the FDA that it intended to market its Model 4011 pacemaker lead as a device that was "substantially equivalent" to devices already on the market. (The lead is the portion of a pacemaker that transmits the heartbeat-steadying electrical signal from the "pulse generator" to the heart itself.) On November 30, 1982, the FDA found that the model was "substantially equivalent to devices introduced into interstate commerce" prior to the effective date of the Act, and advised Medtronic that it could therefore market its device subject only to the general control provisions of the Act, which could be found in the Code of Federal Regulations. See Respondent's Memorandum in Support of Motion for Summary Judgment in No. 93-482 (MD Fla., Nov. 1, 1993), Exh. A to Exh. 1 (Declaration of Charles H. Swanson) (hereinafter FDA Substantial Equivalence Letter). The agency emphasized, however, that this determination should not be construed as an endorsement of the pacemaker lead's safety. Ibid.
Cross-petitioner Lora Lohr is dependent on pacemaker technology for the proper functioning of her heart. In 1987 she was implanted with a Medtronic pacemaker equipped with one of the company's Model 4011 pacemaker leads. On
4 In 1990, Congress enacted amendments to the MDA which were designed to reduce the FDA's reliance on the § 510(k) process while continuing to ensure that particularly risky devices received full PMA review. See Safe Medical Devices Act of 1990.
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