BLAZER PRIME XP CATHETER
FDA premarket approval P020025/S023 · decided 2010-06-30
Approval details
- PMA number
- P020025
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER PRIME XP CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2010-05-27
- Decision date
- 2010-06-30
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A 70% ISOPROPYL ALCOHOL WIPE IN THE MANUFACTURING PROCESS.
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