PMA P080014S010

Device: CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)
Applicant: Hologic, Inc.
PMA number: P080014
Supplement: S010
Product code: MAQ
Decision date: 2012-01-20
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: CHANGE TO REPLACE QUALITY CONTROL TEST METHOD CONTROLS WITH NEW QUALITY CONTROL TEST METHOD CONTROLS FROM THE SAME SUPPLIER FOR INCOMING MATERIALS INSPECTION TESTING AND IN-PROCESS QUALITY CONTROL TESTING OF ACCESSORY KIT REAGENTS.

Current openFDA PMA Record#

Device: CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)
Applicant: Hologic, Inc.
PMA number: P080014
Supplement: S010
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2012-01-20
Decision code: OK30
Date received: 2011-12-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO REPLACE QUALITY CONTROL TEST METHOD CONTROLS WITH NEW QUALITY CONTROL TEST METHOD CONTROLS FROM THE SAME SUPPLIER FOR INCOMING MATERIALS INSPECTION TESTING AND IN-PROCESS QUALITY CONTROL TESTING OF ACCESSORY KIT REAGENTS.