PMA P020018S032
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S032
- Product code
- MIH
- Decision date
- 2009-04-02
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE TOP CAP TRIGGER WIRE, DELIVERY SYSTEM POSITIONER, AND TRIGGER KNOB SET SCREW.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S032
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-04-02
- Decision code
- APPR
- Date received
- 2009-02-23
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE TOP CAP TRIGGER WIRE, DELIVERY SYSTEM POSITIONER, AND TRIGGER KNOB SET SCREW.