PMA P100029S047
- Device
- Trifecta™ Valve with Glide Technology™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100029
- Supplement
- S047
- Product code
- LWR
- Decision date
- 2022-11-29
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Modifications to a controlled access environment (CAE) and relocation of manufacturing processes within the CAE.
Current openFDA PMA Record#
- Device
- Trifecta™ Valve with Glide Technology™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100029
- Supplement
- S047
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-11-29
- Decision code
- OK30
- Date received
- 2022-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to a controlled access environment (CAE) and relocation of manufacturing processes within the CAE.