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.
| Device | BLAZER™ OPEN-IRRIGATED Ablation Catheter, INTELANAV™ OPEN-IRRIGATED Ablation Catheter, INTELLANAV MIFI™ OPEN-IRRIGATED A |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS071 Date Received08/22/2022 Decision Date09/21/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-22 |
| Decision Date | 2022-09-21 |
| PMA | P150005 |
| Supplement | S071 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 PMA NumberP150005 Supplement NumberS071 Date Received08/22/2022 Decision Date09/21/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Modified Adhesive Curing Process And Parameters |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150005 | Original Filing | |
| S073 | 2022-10-17 | 30-day Notice |
| S072 | 2022-08-26 | Real-time Process |
| S071 | 2022-08-22 | 30-day Notice |
| S070 | 2022-01-28 | 30-day Notice |
| S069 | 2022-01-24 | 30-day Notice |
| S068 | 2021-11-10 | 30-day Notice |
| S067 | 2021-08-13 | 30-day Notice |
| S066 | 2021-07-08 | 30-day Notice |
| S065 | 2021-06-25 | 30-day Notice |
| S064 | 2021-06-24 | 30-day Notice |
| S063 | 2021-06-21 | 30-day Notice |
| S062 | 2021-02-22 | Normal 180 Day Track No User Fee |
| S061 | ||
| S060 | 2020-11-16 | 30-day Notice |
| S059 | 2020-11-12 | 30-day Notice |
| S058 | 2020-09-29 | Normal 180 Day Track |
| S057 | 2020-09-28 | Real-time Process |
| S056 | 2020-05-21 | 30-day Notice |
| S055 | 2020-05-15 | 30-day Notice |
| S054 | 2020-04-30 | Normal 180 Day Track No User Fee |
| S053 | 2020-03-12 | Normal 180 Day Track No User Fee |
| S052 | 2020-01-22 | 30-day Notice |
| S051 | 2019-11-22 | Real-time Process |
| S050 | 2019-10-10 | 30-day Notice |
| S049 | ||
| S048 | 2019-09-30 | 30-day Notice |
| S047 | 2019-06-14 | Real-time Process |
| S046 | 2019-05-08 | 30-day Notice |
| S045 | ||
| S044 | 2019-04-08 | 30-day Notice |
| S043 | ||
| S042 | 2019-03-20 | 30-day Notice |
| S041 | 2018-10-25 | 135 Review Track For 30-day Notice |
| S040 | 2018-08-24 | 30-day Notice |
| S039 | 2018-06-21 | Normal 180 Day Track |
| S038 | 2018-06-13 | 30-day Notice |
| S037 | 2018-04-27 | Normal 180 Day Track No User Fee |
| S036 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S035 | 2018-02-02 | Normal 180 Day Track |
| S034 | 2018-01-17 | 30-day Notice |
| S033 | 2017-12-15 | Real-time Process |
| S032 | 2017-10-30 | 30-day Notice |
| S031 | 2017-10-26 | 30-day Notice |
| S030 | 2017-10-02 | 30-day Notice |
| S029 | 2017-09-15 | 30-day Notice |
| S028 | 2017-09-14 | 30-day Notice |
| S027 | 2017-08-30 | 30-day Notice |
| S026 | 2017-08-25 | 30-day Notice |
| S025 | 2017-08-14 | 30-day Notice |
| S024 | 2017-08-04 | 30-day Notice |
| S023 | 2017-07-18 | 30-day Notice |
| S022 | 2017-06-26 | 30-day Notice |
| S021 | 2017-05-18 | 30-day Notice |
| S020 | 2017-04-27 | Real-time Process |
| S019 | 2017-04-13 | 30-day Notice |
| S018 | 2017-03-17 | 30-day Notice |
| S017 | 2017-03-16 | Normal 180 Day Track |
| S016 | 2017-03-06 | 30-day Notice |
| S015 | 2017-03-03 | Real-time Process |
| S014 | 2017-02-22 | Panel Track |
| S013 | 2016-11-17 | Normal 180 Day Track No User Fee |
| S012 | 2016-11-09 | 30-day Notice |
| S011 | 2016-11-07 | 135 Review Track For 30-day Notice |
| S010 | 2016-07-21 | 30-day Notice |
| S009 | 2016-07-21 | 30-day Notice |
| S008 | 2016-05-02 | Normal 180 Day Track |
| S007 | 2016-04-15 | 135 Review Track For 30-day Notice |
| S006 | 2016-04-11 | Normal 180 Day Track No User Fee |
| S005 | 2016-04-11 | Normal 180 Day Track |
| S004 | 2016-03-21 | 135 Review Track For 30-day Notice |
| S003 | ||
| S002 | 2016-03-01 | 30-day Notice |
| S001 | 2016-03-01 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729862246 | P150005 | 000 |
| 08714729862208 | P150005 | 000 |
| 08714729862253 | P150005 | 000 |
| 08714729862239 | P150005 | 000 |
| 08714729862222 | P150005 | 000 |
| 08714729937432 | P150005 | 005 |
| 08714729937449 | P150005 | 005 |
| 08714729937456 | P150005 | 005 |
| 08714729848707 | P150005 | 008 |
| 08714729848691 | P150005 | 008 |
| 08714729848684 | P150005 | 008 |
| 08714729938385 | P150005 | 017 |
| 08714729938361 | P150005 | 017 |
| 08714729938378 | P150005 | 017 |
| 08714729992240 | P150005 | 074 |
| 08714729992233 | P150005 | 074 |
| 00191506020408 | P150005 | 074 |
| 00191506034429 | P150005 | 074 |
| 00191506020798 | P150005 | 079 |