ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
FDA premarket approval P020018/S016 · decided 2007-08-30
Approval details
- PMA number
- P020018
- Supplement
- S016
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2006-09-18
- Decision date
- 2007-08-30
- Days to decision
- 346 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR THE ADDITION OF ALTERNATE VENDORS FOR 1) THE 5-0 GREEN BRAIDED POLYESTER SUTURE AND 2) THE 5-0 BLUE MONOFILAMENT POLYPROPYLENE SUTURE.
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