[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]
BILLING CODE 4160-01-F
