PMA P080014S009

Device: CERVISTA HPV HR COMPONENTS
Applicant: Hologic, Inc.
PMA number: P080014
Supplement: S009
Product code: MAQ
Decision date: 2011-08-02
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: CHANGE IN THE STATISTICAL METHOD EMPLOYED DURING INCOMING MATERIAL INSPECTION OF THE HPV CONTROLS OF THE CERVISTA® HPV HR AND REAGENTS IN THE GENFIND® DNA EXTRACTION KIT.

Current openFDA PMA Record#

Device: CERVISTA HPV HR COMPONENTS
Applicant: Hologic, Inc.
PMA number: P080014
Supplement: S009
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2011-08-02
Decision code: OK30
Date received: 2011-07-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE STATISTICAL METHOD EMPLOYED DURING INCOMING MATERIAL INSPECTION OF THE HPV CONTROLS OF THE CERVISTA® HPV HR AND REAGENTS IN THE GENFIND® DNA EXTRACTION KIT.