BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES
FDA premarket approval P020025/S029 · decided 2012-03-23
Approval details
- PMA number
- P020025
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2011-06-21
- Decision date
- 2012-03-23
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.