Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Blazer II XP; Blazer Prime XP |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P020025 |
Supplement Number | S093 |
Date Received | 11/22/2016 |
Decision Date | 12/23/2016 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the Ultrasonic Welding process used to secure the steering knob during manufacture of Blazer II, Blazer II XP, Blazer II HTD, Blazer Prime XP, and Blazer Prime HTD temperature ablation catheters. |
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