ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
FDA premarket approval P040012/S003 · decided 2006-03-16
Approval details
- PMA number
- P040012
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2005-12-22
- Decision date
- 2006-03-16
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL OF MODIFICATIONS TO THE PROTOCOL FOR THE ARCHER LONG TERM FOLLOW-UP (LTFU) TRIAL. THE REVISED PROTOCOL INCLUDES MEASURES DESIGNED TO ASSIST IN THE RECRUITMENT AND EVALUATION OF PATIENTS, AND COMPLIES WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 30, 2004 APPROVAL ORDER FOR P040012.
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510(k) clearances by this applicant
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|---|---|---|
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| HI-TORQUE TurnTrac Guide Wire Family (K173795) | Abbott Vascular | 2018-01-12 |