STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
FDA premarket approval P990071 · decided 2000-05-31
Approval details
- PMA number
- P990071
- Trade name
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Biosense Webster, Inc.
- Date received
- 1999-11-09
- Decision date
- 2000-05-31
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- THE STOCKERT 70 RF GENERATOR SYSTEM IS INDICATED FOR USE WITH A BIOSENSE WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER TO DELIVER RF ENERGY DURING CARDIAC ABLATION PROCEDURES.
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510(k) clearances by this applicant
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|---|---|---|
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