cobas HPV

FDA Premarket Approval P190028 S003

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

The sponsor has proposed changes to the products identified above as the outcome of periodic internal reviews of hazard information. Per the sponsor, hazard information is compared against the most current safety data sheet to confirm whether any updates are reflected in product labeling. The sponsor notes that updates to the product hazard information strengthen instructions to enhance the safe use of the device. Review of the redlined versions of labeling, included in the submission, confirms that there are no changes to product formulation or changes to how the user interacts with the product. The changes do not pose any safety or efficacy concerns and accordingly are acceptable.

Devicecobas HPV
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantRoche Molecular Systems, Inc.
Date Received2020-09-17
Decision Date2020-10-07
PMAP190028
SupplementS003
Product CodeMAQ 
Advisory CommitteeMicrobiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P190028Original Filing
S003 2020-09-17 Special (immediate Track)
S002 2020-07-27 30-day Notice
S001 2020-04-10 30-day Notice

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