[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Pages 49693-49694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25180]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0392]
Mallinckrodt, Inc.; Premarket Approval of Albunex
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 supplemental application by Mallinckrodt, Inc., St.
Louis, MO, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act (the act), of Albunex . After reviewing the
recommendation of the Radiological Devices Panel, FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant, by
letter of June 17, 1997, of the approval of the supplemental
application.
DATES: Petitions for administrative review by October 23, 1997.
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: Robert A. Phillips, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1212.
SUPPLEMENTARY INFORMATION: On September 3, 1995, Mallinckrodt, Inc.,
St. Louis, MO 63134, submitted to CDRH a supplemental application for
premarket approval of Albunex . The device is an ultrasound contrast
agent and is indicated for use with transvaginal ultrasound to assess
fallopian tube patency.
On February 24, 1997, the Radiological Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the supplemental application. On June 17, 1997,
CDRH approved the supplemental application by a letter to the applicant
from the Deputy Director of Clinical and Review Policy 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 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 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 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
[[Page 49694]]
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 October 23, 1997, 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: August 26, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-25180 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F
