Medical Devices; Availability of Summaries of Safety and Effectiveness

In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule to revise Secs. 814.44(d) and 814.45(d) (21 CFR 814.44(d) and 814.45(d) to discontinue publication of individual PMA approvals and denials in the Federal Register. Revised Secs. 814.44(d) and 814.45(d) state that FDA will notify the public of PMA approvals and denials by posting them on FDA's home page on the Internet (https:// www.fda.gov), by placing the summaries of safety and effectiveness on the Internet and in FDA's Dockets Management Branch, and by publishing in the Federal Register after each quarter a list of the PMA approvals and denials announced in that quarter. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)) notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant: in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The following is a list of all PMA applications for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure as explained previously through March 31, 1999. There were no denial actions during this period. The list provides the manufacturer's name, the generic name or the trade name, and the approval date.

Table 1.--List of Approved PMA's From September 25, 1998 through December 31, 1998 ------------------------------------------------------------------------ PMA Number/Docket No. Applicant Trade Name Approval Date ------------------------------------------------------------------------ P970026/98M-0722 Miriad Ultra Sound Scan 2000 May 29, 1998 Sound, Inc. Sound Scan Compact Sound Scan Clinical Bone Sonometer P970034/98M-0855 Ophthalmic Ophthalmic September 25, Innovations Innovations 1998 International, International Inc. Modified C-Loop P980017/98M-0835 Possis Medical, Perma-Seal September 25, Inc. Dialysis Access 1998 Graft Model 2C20 P980018/98M-0857 DAKO A/S DAKO Herceptest September 25, 1998 P980025/98M-0856 Logicon RDA Logicon Caries September 25, Detector 1998 P960014/98M-0897 Global Magellan-C Ooctober 5, 1998 Therapeutics, Percutaneous Inc. Transluminal Coronary Angioplasty (PTCA) Catheters Model C22020, C22520, C23020, & C23520 P980016/98M-0907 Medtronic, Inc. Medtronic Gem Dr October 9, 1998 Model 7271 Dual Chamber Implantable Cardioverter Defibrillator System with Model 9960 (Gem Dr) Applicator P980023/98M-0972 Biotronik, Inc Phylax October 27, 1998 Implantable Cardioverter Defibrillator System D970012/98M-0999 American Medical AMS 700 Series November 2, 1998 Systems, Inc. Inflatable Penile Prosthesis Product Line; AMS700CX, AMS700CXM, AMS700CX Preconnect, AMS 700 Ultrex and AMS 700 Ultrex Plus P980024/99M-0034 Vysis, Inc. Path VysionTM; December 11, HER-2 DNA Probe 1998 Kit P960025/99M-0894 Acromed Corp. Brantigen I/F February 2, 1999 Cage Used with VSP Spine Plates and Pedicle Screws P980006/99M-0237 Bausch & Lomb Pure VisionTM February 5, 1999 Inc. Balafilcon A Visibility Tinted Contact Lens P980041/99M-0793 Beckman Coulter, Access AFP February 8, 1999 Inc. Reagents on the Access Immunoassay Analyzer ------------------------------------------------------------------------

Dated: June 9, 1999. Linda S. Kahan, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 99-15755 Filed 6-21-99; 8:45 am] BILLING CODE 4160-01-F