PMA P100029S033

Device: Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)
Applicant: ABBOTT MEDICAL
PMA number: P100029
Supplement: S033
Product code: LWR
Decision date: 2018-04-19
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Installation of additional data loggers for use with the Vaisala Environmental Monitoring System in the Pampulha, Brazil manufacturing site.

Current openFDA PMA Record#

Device: Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)
Applicant: ABBOTT MEDICAL
PMA number: P100029
Supplement: S033
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2018-04-19
Decision code: OK30
Date received: 2018-03-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Installation of additional data loggers for use with the Vaisala Environmental Monitoring System in the Pampulha, Brazil manufacturing site.