Looking for a Premarket Approval (PMA) Template or checklist

[Ballroom Blitz]

Hi
Does anyone have the following:
1)a PMA template (redacted)
2)PMA checklist
they can share?
This is for a combination product, no software sections.

Our company has never done a PMA before so I am starting from scratch and its been 5 years since I worked on an original PMA.

Any help would be appreciated.

 

[Stijloor]

A Quick Bump!

Can someone help with this request?

We appreciate your willingness to lend a hand.

 

[Ronen E]

The long version:
https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM313368.pdf

The short version:
https://www.fda.gov/MedicalDevices/...ubmissions/PremarketApprovalPMA/ucm050289.htm

 

[Ballroom Blitz]

I was looking for a template someone created for a submission, table of contents
She'll for a PMA.
The FDA links to guidance are already obvious to me ! So that doesn't answer my question.
I can understand an inability to share a table of contents, even if redacted

 

[Ronen E]

I was looking for a template someone created for a submission, table of contents
She'll for a PMA.
The FDA links to guidance are already obvious to me ! So that doesn't answer my question.
I can understand an inability to share a table of contents, even if redacted

Well, sometimes you don't get exactly what you're looking for, even in Elsmar. If I had such a template that I could share, I would have shared it. Hopefully someone else will be more instrumental.

I shared the 2 links because:
1. Personally I prefer the source as my checklist, not something someone I don't know created for purposes I don't necessarily know (might be right for them but wrong for me).
2. You noted that it's been 5 years since you authored an original PMA and the guidance document is newer than that so I thought you might be unaware of it.

Peace,
Ronen.