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 Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a |
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 | S108 |
Date Received | 10/02/2017 |
Decision Date | 11/01/2017 |
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 Update the software control system and the vacuum pump used in Sterilization Chamber 1 at the BSC Coventry Rhode Island facility. |
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