CHILLI COOLED ABLATION SYSTEM
FDA premarket approval P990054/S001 · decided 2001-02-15
Approval details
- PMA number
- P990054
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CHILLI COOLED ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2001-01-05
- Decision date
- 2001-02-15
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- APPROVAL FOR AN ACCELERATED AGING PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE OF THE APPROVED DEVICES.
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