BLAZER II XP/PRIME XP CATHETER
FDA premarket approval P020025/S028 · decided 2011-07-19
Approval details
- PMA number
- P020025
- Supplement
- S028
- Trade name
- BLAZER II XP/PRIME XP CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2011-06-09
- Decision date
- 2011-07-19
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.
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