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 | SVS Deployment Catheter and Loader |
| Generic Name | Valve, Pulmonary |
| Applicant | Gyrus ACMI, Inc.6675 185th Avenue Neredmond, WA 98052 PMA NumberP180007 Supplement NumberS009 Date Received04/12/2022 Decision Date05/12/2022 Product Code NJK Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-12 |
| Decision Date | 2022-05-12 |
| PMA | P180007 |
| Supplement | S009 |
| Product Code | NJK |
| Advisory Committee | Anesthesiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Gyrus ACMI, Inc. 6675 185th Avenue Ne redmond, WA 98052 PMA NumberP180007 Supplement NumberS009 Date Received04/12/2022 Decision Date05/12/2022 Product Code NJK Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Minor Change To A Manufacturing Tool Used In The Assembly Of The SVS Deployment Catheter And Loader |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180007 | Original Filing | |
| S009 | 2022-04-12 | 30-day Notice |
| S008 | 2021-04-30 | Normal 180 Day Track No User Fee |
| S007 | 2020-10-21 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2019-11-18 | Normal 180 Day Track |
| S004 | ||
| S003 | 2018-12-26 | Normal 180 Day Track No User Fee |
| S002 | 2018-12-26 | Normal 180 Day Track No User Fee |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00896506002323 | P180007 | 000 |
| 00896506002316 | P180007 | 000 |
| 00896506002309 | P180007 | 000 |
| 00896506002293 | P180007 | 000 |
| 00896506002286 | P180007 | 000 |
| 00896506002279 | P180007 | 000 |