PMA P070027
- Device
- TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070027
- Supplement
- S048
- Product code
- MIH
- Decision date
- 2017-02-01
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for updated in-process sampling requirements and to remove redundant inspections.
Current openFDA PMA Record#
- Device
- TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070027
- Supplement
- S048
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-02-01
- Decision code
- APPR
- Date received
- 2016-08-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updated in-process sampling requirements and to remove redundant inspections.