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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBlazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP020025
Supplement NumberS108
Date Received10/02/2017
Decision Date11/01/2017
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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