OPRA System

FDA Premarket Approval P190009 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p190009.

DeviceOPRA System
Generic NameOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
ApplicantIntegrum AB
Date Received2021-01-15
Decision Date2021-02-12
PMAP190009
SupplementS002
Product CodePJY 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Integrum AB krokslatts Fabriker 50 molndal Se-43-431

Supplemental Filings

Supplement NumberDateSupplement Type
P190009Original Filing
S002 2021-01-15 Normal 180 Day Track No User Fee
S001 2021-01-15 Normal 180 Day Track No User Fee

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