01 · Original application
What was approved originally?
Locate the starting device, decision date and documents. Keep the historical scope separate from later changes.
Read the original PMA guideDevice evidence library
Read a PMA decision in context.
Start with the original application, then follow the specific change cited by a supplier. These guides explain different reading tasks; they do not determine current product eligibility.
02 · Specific supplement
What did this S-number change?
Compare a hardware-design change with a study protocol decision. Keep model references and dates beside the actual change statement.
Read the PMA supplement guideFDA source links, consultation dates and limitations are included in each guide. This navigation index is not an additional evidence study.