BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE
FDA premarket approval P020025/S080 · decided 2015-10-13
Approval details
- PMA number
- P020025
- Supplement
- S080
- 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
- 2015-09-10
- Decision date
- 2015-10-13
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A VACUUM PUMP ANTI-SURGE DEVICE TO THE EXISTING CHAMBER 1 EQUIPMENT AT THE CONTRACT STERILIZER.
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