Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514"

#1
Good afternoon everybody,

Does anyone knows the difference between "Transitional Adolescent A" and "Transitional Adolescent B" on the "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514"? Both have the same description (18 through 21 years of age).

Thanks!
 

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#2
Steve,

when you google for these 2 terms, you find several 510(k)s with this definition:

Transitional Adolescent A (18 - <21 years old) Special considerations are being given to this group, different from adults age => 21 (different device design or testing, different protocol procedures, etc.)

Transitional Adolescent B (18 -<= 21; No special considerations compared to adults => 21 years old)
 
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