ACCULINK CAROTID STENT SYSTEMS
FDA premarket approval P040012/S028 · decided 2008-12-10
Approval details
- PMA number
- P040012
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACCULINK CAROTID STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2008-11-10
- Decision date
- 2008-12-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
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510(k) clearances by this applicant
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|---|---|---|
| NC TREK NEO Coronary Dilatation Catheter (K220634) | Abbott Vascular | 2022-06-30 |
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| HI-TORQUE Steelcore Bare Guide Wire (K200144) | Abbott Vascular | 2020-04-08 |
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| HI-TORQUE TurnTrac Guide Wire Family (K173795) | Abbott Vascular | 2018-01-12 |