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2014-05-29
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Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) to class II (special controls). The Panel made this recommendation after reviewing the reclassification petition submitted by Cook Group Inc. (COOK) and other publicly available information. FDA is also announcing for public comment its tentative findings based on the Panel's recommendation and other publicly available information. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified.
73 FR 31123
https://www.govinfo.gov/app/details/FR-2008-05-30/E8-12079
E8-12079
fr30my08-57
4160-01-S
Docket No. FDA-2000-P-0924
https://www.govinfo.gov/app/details/FR-2008-05-30/E8-12079
https://www.govinfo.gov/content/pkg/FR-2008-05-30/html/E8-12079.htm
https://www.govinfo.gov/content/pkg/FR-2008-05-30/pdf/E8-12079.pdf
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73 FR 31123
Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Federal Register Vol. 73, Issue
NOTICE
E8-12079
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2008-08-28
Docket No. FDA-2000-P-0924
4160-01-S
E8-12079
Notice of panel recommendation.
The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) to class II (special controls). The Panel made this recommendation after reviewing the reclassification petition submitted by Cook Group Inc. (COOK) and other publicly available information. FDA is also announcing for public comment its tentative findings based on the Panel's recommendation and other publicly available information. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified.
Submit written or electronic comments by August 28, 2008.
Kathryn O'Callaghan or Suzanne Kaiser, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276- 4222.
Cardiovascular Devices:
Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm
http://www.regulations.gov
Federal Register
Vol. 73, no. 105
Office of the Federal Register, National Archives and Records Administration
2008-05-30
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https://www.govinfo.gov/content/pkg/FR-2008-05-30/xml/FR-2008-05-30.xml
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