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 | CardioGenesis TMR System |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-08-04 |
| Decision Date | 2022-09-01 |
| PMA | P970029 |
| Supplement | S040 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of Chassis Grounding Resistance And Chassis Leakage Current Tests To The Service Manual For Use After Repair, Maintenance, And Installation Activities |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970029 | Original Filing | |
| S040 | 2022-08-04 | Special (immediate Track) |
| S039 | 2019-04-18 | 30-day Notice |
| S038 | ||
| S037 | 2018-06-12 | 30-day Notice |
| S036 | 2017-08-14 | 30-day Notice |
| S035 | 2017-06-29 | 30-day Notice |
| S034 | 2017-06-09 | Real-time Process |
| S033 | 2017-05-10 | Normal 180 Day Track |
| S032 | 2016-08-12 | Special (immediate Track) |
| S031 | ||
| S030 | 2016-05-25 | 30-day Notice |
| S029 | 2016-05-25 | 30-day Notice |
| S028 | 2015-12-11 | Special (immediate Track) |
| S027 | 2015-02-13 | Normal 180 Day Track No User Fee |
| S026 | 2014-04-09 | Special (immediate Track) |
| S025 | 2013-11-26 | Normal 180 Day Track No User Fee |
| S024 | 2013-01-29 | Real-time Process |
| S023 | ||
| S022 | 2012-10-19 | Normal 180 Day Track No User Fee |
| S021 | 2012-08-16 | Special (immediate Track) |
| S020 | 2012-06-27 | Special (immediate Track) |
| S019 | 2012-03-27 | Normal 180 Day Track No User Fee |
| S018 | 2011-11-17 | 30-day Notice |
| S017 | 2010-03-19 | Special (immediate Track) |
| S016 | ||
| S015 | 2009-08-31 | Normal 180 Day Track No User Fee |
| S014 | 2009-07-30 | Normal 180 Day Track |
| S013 | 2008-10-22 | Normal 180 Day Track No User Fee |
| S012 | 2008-08-15 | Special (immediate Track) |
| S011 | 2007-05-09 | Normal 180 Day Track |
| S010 | ||
| S009 | 2004-03-24 | Normal 180 Day Track |
| S008 | 2001-10-05 | Normal 180 Day Track |
| S007 | 2001-05-25 | Special (immediate Track) |
| S006 | 2001-01-24 | Normal 180 Day Track |
| S005 | 2000-11-09 | Special (immediate Track) |
| S004 | ||
| S003 | 1999-12-06 | Special (immediate Track) |
| S002 | ||
| S001 | 1999-03-26 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00877234000102 | P970029 | 001 |
| 00877234000096 | P970029 | 009 |
| 00877234000119 | P970029 | 011 |