The agency approves p180007/s008/a001 - gyrus acmi (spiration) pas revisions to emprove study protocol. Gyrus acmi (spiration) pas revisions to emprove study protocol. The sponsor submitted an amendment in which the requirements for investigator reports reporting uades, withdrawal of irb approval, progress, deviations, final report, and other reports have been restored. This amendment addresses deficiencies noted in fda letter dated may 28, 2021 from review of pma supplement p18007/s008 and following the june 9, 2021 gyrus-fda conference call which occurred to discuss clarification of the noted deficiencies. The reviewer team has reviewed the amendment that the sponsor provided. The deficiencies that the agency listed are resolved because sponsor has restored the sections that they removed cited in the deficiencies.
| Device | Spiration Valve System |
| Generic Name | Valve, Pulmonary |
| Applicant | Gyrus ACMI, Inc. |
| Date Received | 2021-04-30 |
| Decision Date | 2021-09-01 |
| PMA | P180007 |
| Supplement | S008 |
| Product Code | NJK |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Gyrus ACMI, Inc. 6675 185th Avenue Ne redmond, WA 98052 |
Supplemental Filings
| 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 | | |
NIH GUDID Devices