BRACANALYSIS CDX
FDA premarket approval P140020/S008 · decided 2017-01-30
Approval details
- PMA number
- P140020
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRACANALYSIS CDX
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2016-10-27
- Decision date
- 2017-01-30
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for the inclusion of the BRACAnalysis CDx - DNA Quantification Technical Manual, the BRACAnalysis CDx - Sanger Technical Manual, and the BRACAnalysis CDX BART Technical Manual in place of several laboratory Standard Operating Procedures.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.