(a) Identification. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 20, 2012, for any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976. Any other implantable pacemaker pulse generator device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 37576, June 22, 2012]
Notes of Decisions
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
· cites it 2× “See 21 CFR § 870.3610 (1995). Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a "reasonable assurance" that the device is both safe and effective.”
Ellen Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir. 1994).
“See 21 C.F.R. § 870.3610 (c). Moreover, plaintiff has not alleged that FDA’s substantial equivalence finding was improper.”
Jessen v. Mentor Corp., 71 Cal. Rptr. 3d 714 (Cal. Ct. App. 2008).
“3750 ; see Goldsmith v. Mentor Corp. (D.N.”
Betterton v. Evans, 351 F. Supp. 2d 529 (N.D. Miss. 2004).
· cites it 4× “See 21 C.F.R. § 870.3610 (1995). “Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a ‘reasonable assurance’ that the device is both safe and effective.”
Weiland v. Telectronics Pacing Sys., Inc., 721 N.E.2d 1149 (Ill. 1999).
“21 C.F.R. § 870.3610 (b) (1995). Before a manufacturer can market a Class III medical device which is not “substantially equivalent” to a medical device on the market prior to the enactment of the MDA, the manufacturer must provide the FDA with a “reasonable assurance of the…”
Lake v. TPLC, 1 F. Supp. 2d 84 (D. Mass. 1998).
“See 21 C.F.R. § 870.3610 (1998). Before a new Class III device may be marketed, the manufacturer must provide “reasonable assurance” to the FDA that the device is both safe and effective.”
Fender v. Medtronic, Inc., 887 F. Supp. 1326 (E.D. Cal. 1995).
“21 C.F.R. §§ 870.3610 , 870.3680. The FDA gave premarket approval for the Medtronic pacemaker implanted in Fender.”
Stanfield v. Boston Sci. Corp., 166 F. Supp. 3d 873 (S.D. Tex. 2015).
“§ 360e(f)(l)(when a device receives notice of completion of testing in accordance with PDP, it is considered to have PMLA approval); 21 C.F.R. § 870.3610 (Date PMA or notice of completion of PDP is required “for implantable pacemaker pulse generator”); 21 C.”
Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir. 1995).
“In order to market a Class III device, a manufacturer generally must obtain premarket approval from the FDA.”
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