ACCULINK CAROTID STENT SYSTEM
FDA premarket approval P040012/S033 · decided 2010-10-15
Approval details
- PMA number
- P040012
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACCULINK CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2010-09-17
- Decision date
- 2010-10-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- CHANGE TO THE METHODOLOGY FOR STERILIZATION DOSE AUDITS.
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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 |