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Waverunners

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Waverunners

Re: Waverunners post# 9873

Saturday, 07/16/2022 7:39:47 PM

Saturday, July 16, 2022 7:39:47 PM

Post# of 14067
Link to a PMA supplement completed last week for an established competitor. Every little change has to be documented and approved by FDA. Even for the big boys.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N12159S094

Approval To Establish A New Slit And Cutting Room In The Ethicon LLC San Lorenzo, Puerto Rico Manufacturing Facility.
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