(a) Identification. A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 11, 2000, for any penile inflatable implant that was in commercial distribution before May 28, 1976, or that has, on or before July 11, 2000, been found to be substantially equivalent to a penile inflatable implant that was in commercial distribution before May 28, 1976. Any other penile inflatable implant shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 19658, Apr. 12, 2000]
Notes of Decisions
prod.liab.rep. (Cch) P 14,318 Sam Feldt v. Mentor Corp., 61 F.3d 431 (5th Cir. 1995).
“Although all classes of medical devices are subject to general controls, including labeling requirements and so-called good manufacturing practices (GMPs), Class II and Class III devices are subject to additional regulations. Moreover, because Class III devices are deemed to…”
Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir. 1995).
· cites it 3× “21 C.F.R. § 876.3350 (1994). In order to market a Class III device, a manufacturer generally must obtain premarket approval from the FDA.”
Spier v. Coloplast Corp., 121 F. Supp. 3d 809 (E.D. Tenn. 2015).
“See 21 C.F.R. § 876.3350 (b) (classifying all “penile inflatable implant[s]” as Class III medical devices).”
Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324 (4th Cir. 1997).
“Premarket approval requires submission of a detailed application, including clinical data, manufacturing processes, and proposed labeling, see 21 U.”
Sylvester v. Mentor Corp., 663 So. 2d 176 (La. Ct. App. 1995).
“which cannot be classified as Class I or Class II devices because insufficient information exists to determine that the controls provided for Class I or Class II devices would provide reasonable assurance of the safety and effectiveness of the devices and which are represented…”
Feldt v. Mentor Corp. (5th Cir. 1995).
“21 C.F.R. § 876.3350 (b). Before being marketed and sold, Class III devices must undergo the rigors of Pre-Market Approval (PMA), a lengthy, comprehensive process, at the end of which the FDA determines whether there is "reasonable assurance" that the device under consideration…”
Griffin v. Medtronic Inc (4th Cir. 1996).
“3d at 396 ; 21 C.F.R. § 876.3350 (1995). A manufacturer must generally receive approval from the Food and Drug Administration ("FDA") before marketing a Class III device.”
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