PMA P010023S011

Device: MAXUM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S011
Product code: MPV
Decision date: 2015-05-04
Generic name: Implant, hearing, active, middle ear, partially implanted
Approval order statement: APPROVAL FOR CHANGING THE UNAIDED AIR CONDUCTION THRESHOLD UPPER LIMITS TO 60, 70, AND 85 DB HL AT FREQUENCIES OF 250, 500, AND 1000 HZ, RESPECTIVELY, AND TO 100 DB HL AT 2000, 3000, 4000, AND 6000 HZ AS PART OF THE PATIENT SELECTION CRITERIA.

Current openFDA PMA Record#

Device: MAXUM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S011
Product code: MPV
Generic name: Implant, hearing, active, middle ear, partially implanted
Decision date: 2015-05-04
Decision code: APPR
Date received: 2014-05-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGING THE UNAIDED AIR CONDUCTION THRESHOLD UPPER LIMITS TO 60, 70, AND 85 DB HL AT FREQUENCIES OF 250, 500, AND 1000 HZ, RESPECTIVELY, AND TO 100 DB HL AT 2000, 3000, 4000, AND 6000 HZ AS PART OF THE PATIENT SELECTION CRITERIA.