INTRASTENT DOUBLE STRUT STENT
FDA premarket approval P030045/S001 · decided 2006-02-28
Approval details
- PMA number
- P030045
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTRASTENT DOUBLE STRUT STENT
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2005-07-18
- Decision date
- 2006-02-28
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3, INC., PLYMOUTH, MINNESOTA AND A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC.MINNEAPOLIS, MINNESOTA.
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