Submitting a PMA amendment to the FDA involves providing additional information and an explanation of why the amendment is necessary. According to 21 CFR 814.3(f), a PMA amendment is defined as information an applicant submits to FDA to modify a pending PMA or a pending PMA supplement. The FDA may request the applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary for FDA or the appropriate advisory committee to complete the review of the PMA or PMA supplement (21 CFR 814.37(b)(1)).
A PMA supplement, as described in 21 CFR 814.39(c)(1), is submitted for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA. The information required in a supplement is limited to that needed to support the change. A PMA supplement should include a separate section that identifies each change for which approval is being requested and explains the reason for each such change.
You do not need to submit the entire PMA with your amendments. Instead, you should submit the specific information related to the amendment and a cover sheet explaining the reason for the amendment.
Keep in mind that the specific documents and information required for your PMA amendment will depend on the nature of the amendment and the device in question.
As for the eCopy requirement, the FDA Guidance on the eCopy Program for Medical Device Submissions, (section III. For what submission types is an eCopy required?), states "
...all PMA submission types, including, but not limited to, ... as well as amendments involving changes in the correspondent or ownership and requests for extensions.". That wording is also reflected in section III. (A) of FDA guidance for Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.
For reference:
eCopy Program for Medical Device Submissions
Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
