BLAZER PRIME XP CARDIAC ABLATION CATHETERS
FDA premarket approval P020025/S039 · decided 2013-04-01
Approval details
- PMA number
- P020025
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER PRIME XP CARDIAC ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2013-03-04
- Decision date
- 2013-04-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- IMPLEMENTATION OF ADDITIONAL DATA STORAGE IN AN ELECTRONIC MANUFACTURING TRACEABILITY SYSTEM, INCREASE IN IN-PROCESS INSPECTION FREQUENCY, AND ELIMINATION OF AN INSPECTION STEP AT BATCH SETUP.
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