CHILLI COOLED ABLATION SYSTEM
FDA premarket approval P980003/S001 · decided 1999-06-14
Approval details
- PMA number
- P980003
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- CHILLI COOLED ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 1999-03-03
- Decision date
- 1999-06-14
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval of proposed postapproval study for the Chilli(R) Cooled Ablation System for Ischemic Ventricular Tachycardia.
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|---|---|---|
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