CHILLI COOLED ABLATION SYSTEM
FDA premarket approval P980003/S008 · decided 2003-08-07
Approval details
- PMA number
- P980003
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- CHILLI COOLED ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2003-06-20
- Decision date
- 2003-08-07
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- APPROVAL FOR A CHANGE IN THE POST-APPROVAL STUDY PROTOCOL TO ALLOW FOR THE MAXIMUM LIMIT OF 40 PATIENTS OR 20 PERCENT OF THE TOTAL STUDY ENROLLMENT AT ANY ONE SITE.
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