PMA P990046S035
- Device
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S035
- Product code
- LWQ
- Decision date
- 2013-08-07
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- REVIEW OF: 1) INSTALLATION QUALIFICATION (IQ) REPORTS FOR 4 PIECES OF EQUIPMENTRELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT; AND 2) ONE PROCESS QUALIFICATION (PQ) REPORT FOR ONE PIECE OF EQUIPMENT RELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT. THESE CHANGES APPLY TO THE OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S035
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2013-08-07
- Decision code
- OK30
- Date received
- 2013-07-08
- Supplement type
- 30-Day Notice
- Approval order statement
- REVIEW OF: 1) INSTALLATION QUALIFICATION (IQ) REPORTS FOR 4 PIECES OF EQUIPMENTRELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT; AND 2) ONE PROCESS QUALIFICATION (PQ) REPORT FOR ONE PIECE OF EQUIPMENT RELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT. THESE CHANGES APPLY TO THE OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT.