CHILLI COOLED RF ABLATION SYSTEM
FDA premarket approval P980003 · decided 1999-02-02
Approval details
- PMA number
- P980003
- Trade name
- CHILLI COOLED RF ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 1998-01-30
- Decision date
- 1999-02-02
- Days to decision
- 368 days
- Decision code
- APWD
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- San Jose, CA
- Statement
- Approval for the Chili(R) Cooled Ablation System which includes: 1)Chili(R) Cooled Ablation Catheter, Standard Curve (Model 3005; 2)Chili(R) Cooled Ablation Catheter, Large Curve (Model 3006); RF Generator/Pump System (Model 8004); EGM Bypass Switch Box (model 2035); RF Filter Box (Model 2048); Chili(R) Tubing Kit (Model 2100); EGM/RF Generator Cable (Models 2001 and 2028); and EGM Generator Cable (Model 2002 and 2029). This device is indicated for cardiac electropysiological mapping, delivering
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