BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE
FDA premarket approval P020025/S071 · decided 2015-05-28
Approval details
- PMA number
- P020025
- Supplement
- S071
- 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
- 2015-04-29
- Decision date
- 2015-05-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
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