PMA P060025
- Device
- ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
- Applicant
- Medtronic, Inc.
- PMA number
- P060025
- Supplement
- S014
- Product code
- LWR
- Decision date
- 2019-08-21
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
- Applicant
- Medtronic, Inc.
- PMA number
- P060025
- Supplement
- S002
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-08-21
- Decision code
- APPR
- Date received
- 2008-11-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB