Blazer II XP Cardiac Ablation Catheter and Cable
FDA premarket approval P020025/S104 · decided 2017-08-17
Approval details
- PMA number
- P020025
- Supplement
- S104
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Blazer II XP Cardiac Ablation Catheter and Cable
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2017-07-18
- Decision date
- 2017-08-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Sterilize the devices within the scope of this bundled submission by the optimized BSC2000-2 cycle in Chambers 1, 2, 3, 6, 8, 9 and 10 at BSC Coventry, Rhode, Island.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.