CHILLI COOLED ABLATION SYSTEM
FDA premarket approval P980003/S002 · decided 1999-05-06
Approval details
- PMA number
- P980003
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHILLI COOLED ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 1999-04-14
- Decision date
- 1999-05-06
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval for hardware and software changes made to support a single board computer, as well as software changes to allow the use of user-selected flow rates for the pump.
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