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Posted On: 06/26/2019 3:56:40 PM
Post# of 7931
BIEL's application is through the 510k process rodman, so you will want to follow the 510k Database. The PMA process is for devices that can not establish a Predicate Device. Fortunately BIEL has several Predicates.
The weekly 510k Database update occurs on Mondays. Just open the database, enter your Decision Dates, for Monday 7/1 the dates would be 6/23/2019 - 6/30/2019, and hit Search. All of the Clearances for the past week will come up, usually about 60. If nothing comes up the database has not been updated yet, try back in an hour.
https://www.accessdata.fda.gov/scripts/cdrh/c...MN/pmn.cfm
It would be nice if we got a 2 for 1 PR, RecoveryRx Cleared for Post-Op and new Full Body Aplication has been submitted.
The weekly 510k Database update occurs on Mondays. Just open the database, enter your Decision Dates, for Monday 7/1 the dates would be 6/23/2019 - 6/30/2019, and hit Search. All of the Clearances for the past week will come up, usually about 60. If nothing comes up the database has not been updated yet, try back in an hour.
https://www.accessdata.fda.gov/scripts/cdrh/c...MN/pmn.cfm
It would be nice if we got a 2 for 1 PR, RecoveryRx Cleared for Post-Op and new Full Body Aplication has been submitted.
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