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Re: band aid post# 5586

Wednesday, 10/14/2020 10:16:58 AM

Wednesday, October 14, 2020 10:16:58 AM

Post# of 13869
There really shouldn’t be any confusion about where the APPLICATION stand at this point.
But here it is one more time.

From UHP:
The company expects the FDA to grant approval to its PMA (Class III) application or request additional information within 30 days.

From FDA:
“ The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.“