PMA P990017S008
- Device
- ANCURE ENDOGRAFT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P990017
- Supplement
- S008
- Product code
- MIH
- Decision date
- 2000-10-16
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR ENHANCEMENTS TO THE MANUFACTURING PROCESS FOR THE ANCURE SYSTEM
Current openFDA PMA Record
- Device
- ANCURE ENDOGRAFT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P990017
- Supplement
- S008
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2000-10-16
- Decision code
- APPR
- Date received
- 2000-08-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ENHANCEMENTS TO THE MANUFACTURING PROCESS FOR THE ANCURE SYSTEM