BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI
FDA premarket approval P920047/S058 · decided 2013-07-22
Approval details
- PMA number
- P920047
- Supplement
- S058
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2013-03-25
- Decision date
- 2013-07-22
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO MOVE THE EXTRUSION PROCESS FOR BLAZER PRIME ABLATIONCATHETERS TO A NEW MANUFACTURING LINE INTRODUCING AN AUTOMATED PROCESS TO IDENTIFY AND CUTMARKED SECTIONS OF THE EXTRUDED SHAFT.
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