BLAZER II XP AND BLAZER XP RPM CATHETERS
FDA premarket approval P920047/S024 · decided 2004-07-27
Approval details
- PMA number
- P920047
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BLAZER II XP AND BLAZER XP RPM CATHETERS
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2004-05-26
- Decision date
- 2004-07-27
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ELIMINATION OF EXCESS WIRING IN THE SUBASSEMBLY OF THE BLAZER II XP AND BLAZER XP RPM CATHETERS.
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