MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM
FDA premarket approval P070012/S001 · decided 2008-03-06
Approval details
- PMA number
- P070012
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular
- Date received
- 2008-02-04
- Decision date
- 2008-03-06
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE BY THE VENDOR OF THE EXPONENT RX PACKAGING HEADER POUCH TO THE EQUIPMENT USED TO PRODUCE THE VENDOR-SUPPLIED SEALS.
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