Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 214

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 214
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The FDA will approve the new
device for commercial distribution if it determines that the data and information in the PMA application constitute valid scientific evidence
and that there is reasonable assurance that the device is safe and effective for its intended use(s). A PMA may include post-approval
conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion,
sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported the PMA or requirements
to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when
deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population
or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years
and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can
result in material adverse enforcement action, including withdrawal of the approval.

Certain changes to an approved
device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications,
which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission
of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the
device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other
changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode
of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be
developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance
of safety and effectiveness. None of our products are currently marketed pursuant to a PMA.

De Novo Classification

Medical device types that the
FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of
the level of risk they pose. To market low to moderate risk medical devices that are automatically placed into Class III due to the
absence of a predicate device, a manufacturer may request a De Novo down-classification.