PMA P990017S013
- Device
- ANCURE ENDOGRAFT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P990017
- Supplement
- S013
- Product code
- MIH
- Decision date
- 2000-12-28
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE ADDITION OF WARNING IN THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record
- Device
- ANCURE ENDOGRAFT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P990017
- Supplement
- S013
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2000-12-28
- Decision code
- APPR
- Date received
- 2000-11-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF WARNING IN THE INSTRUCTIONS FOR USE.