[Federal Register Volume 61, Number 137 (Tuesday, July 16, 1996)]
[Notices]
[Pages 37071-37072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0239]


Arrow International; Premarket Approval of the Model 3000 
Constant Flow Inplantable Pump with Bolus Safety Valve

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Arrow International, Walpole, MA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the Model 3000 Constant Flow Implantable Infusion Pump with 
Bolus Safety Valve. After reviewing the recommendation of the General 
Hospital and Personal Use Device Section of the General Medical Devices 
Panel, FDA's Center for Devices and Radiological Health (CDRH) notified 
the applicant, by letter of March 11, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by August 15, 1996.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:  Richard E. Galgon, Center for Devices 
and Radiological Health (HFZ-420), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1287.

SUPPLEMENTARY INFORMATION: On September 18, 1990, Arrow International, 
Walpole, MA 02081, submitted to CDRH an application for premarket 
approval of the Model 3000 Constant Flow Implantable Infusion Pump with 
Bolus Safety Valve. The device is an implantable infusion pump and is 
indicated for the continuous regional intra-arterial delivery of 2'-
deoxy-5-fluorouridine (FUDR), heparinized saline, normal saline, and 
bacteriostatic water.
    -On March 5, 1991, the General Hospital and Personal Use Device 
Section of the General Medical Devices Panel of the Medical Devices 
Advisory Committee, an FDA advisory committee, reviewed and recommended 
approval of the application. On March 11, 1996, CDRH approved the 
application by a letter to the applicant from the Director of the 
Office of Device Evaluation, CDRH.
    -A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

 Opportunity for Administrative Review

     Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested

[[Page 37072]]

person to petition, under section 515(g) of the act, for administrative 
review of CDRH's decision to approve this application. A petitioner may 
request either a formal hearing under part 12 (21 CFR part 12) of FDA's 
administrative practices and procedures regulations or a review of the 
application and CDRH's action by an independent advisory committee of 
experts. A petition is to be in the form of a petition for 
reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner 
shall identify the form of review requested (hearing or independent 
advisory committee) and shall submit with the petition supporting data 
and information showing that there is a genuine and substantial issue 
of material fact for resolution through administrative review. After 
reviewing the petition, FDA will decide whether to grant or deny the 
petition and will publish a notice of its decision in the Federal 
Register. If FDA grants the petition, the notice will state the issue 
to be reviewed, the form of the review to be used, the persons who may 
participate in the review, the time and place where the review will 
occur, and other details.
    -Petitioners may, at any time on or before August 15, 1996, file 
with the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    -This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: June 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-17956 Filed 7-15-96; 8:45 am]
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