ANCURE ENDOCRAFT SYSTEM
FDA premarket approval P990017/S034 · decided 2002-07-24
Approval details
- PMA number
- P990017
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANCURE ENDOCRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Boston Scientific Corp
- Date received
- 2002-06-26
- Decision date
- 2002-07-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE MANUFACTURING PROCESS FOR THE ANCURE ENDOGRAFT SYSTEM TO ADD AN INSPECTION STEP IN ONE MANUFACTURING PROCEDURE FOR THE CONTRALATERAL PULLWIRE.
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