Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)

FDA Premarket Approval P150041 S004

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

Qc/manufacturing equipment changes and dna ladder changes.

• Device: Vysis CLL FISH Probe Kit
• Classification Name: Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
• Generic Name: Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
• Applicant: ABBOTT MOLECULAR, INC.
• Date Received: 2018-08-10
• Decision Date: 2018-08-29
• PMA: P150041
• Supplement: S004
• Product Code: PNK
• Advisory Committee: Pathology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement Number	Date	Supplement Type
P150041		Original Filing
S006	2020-11-16	30-day Notice
S005	2019-04-10	30-day Notice
S004	2018-08-10	30-day Notice
S003	2018-06-15	30-day Notice
S002	2018-02-16	30-day Notice
S001	2017-11-08	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00884999042780	P150041	000