BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER
FDA premarket approval P920047/S036 · decided 2006-12-21
Approval details
- PMA number
- P920047
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2006-09-21
- Decision date
- 2006-12-21
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATION OF THE STEERING MECHANISM FOR THE N4 CURVE VERSION OF THE BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER AND THE USE OF A NEW SOLDERING FIXTURE IN THE MANUFACTURING PROCESS.
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