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 | OPTIMIZER Smart, OPTIMIZER Smart Mini |
| Generic Name | Implantable Pulse Generator |
| Applicant | Impulse Dynamics (USA), Inc.30 Ramland Road South, Suite 204orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-07-22 |
| Decision Date | 2022-08-18 |
| PMA | P180036 |
| Supplement | S015 |
| Product Code | QFV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Impulse Dynamics (USA), Inc. 30 Ramland Road South, Suite 204 orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Conditions Of Approval For Nonclinical MR Testing. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180036 | Original Filing | |
| S015 | 2022-07-22 | Normal 180 Day Track No User Fee |
| S014 | ||
| S013 | ||
| S012 | ||
| S011 | 2021-09-28 | Real-time Process |
| S010 | 2021-09-16 | Normal 180 Day Track No User Fee |
| S009 | ||
| S008 | 2021-06-24 | Normal 180 Day Track |
| S007 | 2020-09-09 | Normal 180 Day Track |
| S006 | 2020-06-22 | Normal 180 Day Track |
| S005 | 2020-02-26 | Normal 180 Day Track |
| S004 | 2020-01-09 | Real-time Process |
| S003 | 2019-08-21 | Normal 180 Day Track |
| S002 | 2019-06-21 | Real-time Process |
| S001 | 2019-04-26 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00810003380029 | P180036 | 000 |
| 00810003380012 | P180036 | 000 |
| 00810003380005 | P180036 | 000 |
| 00810003380050 | P180036 | 000 |
| 00810003380043 | P180036 | 000 |
| 00810003380074 | P180036 | 007 |
| 00810003380067 | P180036 | 007 |
| 00810003380081 | P180036 | 007 |
| 00810003380098 | P180036 | 007 |
| 00810003380142 | P180036 | 021 |
| 00810003380135 | P180036 | 021 |