federal_register: 2011-19959
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-19959 | Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode | Proposed Rule | The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments device: Cardiovascular permanent pacemaker electrode. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cardiovascular permanent pacemaker electrode based on new information. This action implements certain statutory requirements. | 2011-08-08 | 2011 | 8 | https://www.federalregister.gov/documents/2011/08/08/2011-19959/effective-date-of-requirement-for-premarket-approval-for-cardiovascular-permanent-pacemaker | https://www.govinfo.gov/content/pkg/FR-2011-08-08/pdf/2011-19959.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments device: Cardiovascular... |