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Types of Postmarket Modifications Approved Changes to Devices
| Type of Modification | Count |
|---|---|
| Labeling change – indications/instructions/shelf life/trade name | 139 |
| Change design/components/specifications/material | 123 |
| Other report | 3 |
| Process change – manufacturer/sterilizer/packager/supplier | 620 |
| Special report | 1 |
| Before PMA pathway | 11 |
| Total | 897 |
Refer PMA Database PMA Number (P800022-S035, P950032-S002, P950032-S028) for details.
