federal_register: E8-12079
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-12079 | Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters | Notice | 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 Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified. | 2008-05-30 | 2008 | 5 | https://www.federalregister.gov/documents/2008/05/30/E8-12079/cardiovascular-devices-reclassification-of-certain-percutaneous-transluminal-coronary-angioplasty | https://www.govinfo.gov/content/pkg/FR-2008-05-30/pdf/E8-12079.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |