BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES
FDA premarket approval P020025/S069 · decided 2015-04-23
Approval details
- PMA number
- P020025
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-04-13
- Decision date
- 2015-04-23
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ACCEPTANCE OF A NEW TRACEABILITY AND TRACKING SYSTEM AT THE SAN JOSE, CALIFORNIA LOCATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.