PMA P040008S002

Device: VIDAS TOTAL PSA (TPSA)
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S002
Product code: MTF
Decision date: 2012-02-08
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.

Current openFDA PMA Record#

Device: VIDAS TOTAL PSA (TPSA)
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S002
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2012-02-08
Decision code: OK30
Date received: 2012-01-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.