PMA P100029S005
- Device
- TRIFECTA VALVE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100029
- Supplement
- S005
- Product code
- LWR
- Decision date
- 2011-07-01
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- AUTOMATED METHOD FOR STENT DIMENSIONAL INSPECTION.
Current openFDA PMA Record#
- Device
- TRIFECTA VALVE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100029
- Supplement
- S005
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2011-07-01
- Decision code
- OK30
- Date received
- 2011-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AUTOMATED METHOD FOR STENT DIMENSIONAL INSPECTION.