PMA P040021S040
- Device
- Biocor and Epic Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S040
- Product code
- LWR
- Decision date
- 2019-03-25
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Modification to the air quality testing method and air microbe action and alert levels.
Current openFDA PMA Record#
- Device
- Biocor and Epic Valves
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S040
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-03-25
- Decision code
- OK30
- Date received
- 2019-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the air quality testing method and air microbe action and alert levels.