PMA P040021S012
- Device
- ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S012
- Product code
- LWR
- Decision date
- 2010-11-05
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR REMOVAL OF A FINAL PRODUCT QUALITY INSPECTION.
Current openFDA PMA Record#
- Device
- ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S012
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2010-11-05
- Decision code
- APPR
- Date received
- 2010-06-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR REMOVAL OF A FINAL PRODUCT QUALITY INSPECTION.