ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
FDA premarket approval P020018/S015 · decided 2006-10-18
Approval details
- PMA number
- P020018
- Supplement
- S015
- Supplement type
- 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
- 2006-10-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- ASSEMBLY OF RAW MATERIAL KITS TO FACILITATE CONSTRUCTION OF LEG EXTENSION GRAFT SUBASSEMBLIES, AND TO ALLOW LEG EXTENSION GRAFT SUBASSEMBLIES TO BE PRODUCED BY A CONTRACT MANUFACTURER.
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