PMA P950039S017

Device: THINPREP 2000 SYSTEM
Applicant: Hologic, Inc.
PMA number: P950039
Supplement: S017
Product code: MKQ
Decision date: 2006-10-05
Classification: Processor, Cervical Cytology Slide, Automated
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL FOR LABELING CHANGES REGARDING WARNING AND HANDLING/DISPOSAL INSTRUCTIONS FOR THINPREP 2000 PROCESSORS THAT HAVE BEEN CONTAMINATED WITH TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE).

Current openFDA PMA Record#

Device: THINPREP 2000 SYSTEM
Applicant: Hologic, Inc.
PMA number: P950039
Supplement: S017
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2006-10-05
Decision code: APPR
Date received: 2006-09-05
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES REGARDING WARNING AND HANDLING/DISPOSAL INSTRUCTIONS FOR THINPREP 2000 PROCESSORS THAT HAVE BEEN CONTAMINATED WITH TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE).