MULTI-LINK VISION,MULTI-LINK MINI VISION,MULTI-LINK 8 CORONARY STENT SYSTEMS
FDA premarket approval P020047/S061 · decided 2015-02-06
Approval details
- PMA number
- P020047
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MULTI-LINK VISION,MULTI-LINK MINI VISION,MULTI-LINK 8 CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2015-01-14
- Decision date
- 2015-02-06
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
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510(k) clearances by this applicant
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| HI-TORQUE PROCEED Guide Wire Family (K201834) | Abbott Vascular | 2020-07-30 |
| 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 |