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 | LASTAC SYSTEM |
| Classification Name | Device, Angioplasty, Laser, Coronary |
| Generic Name | Device, Angioplasty, Laser, Coronary |
| Applicant | G V MEDICAL, INC, |
| Date Received | 1988-12-12 |
| Decision Date | 1989-04-04 |
| PMA | P870071 |
| Supplement | S002 |
| Product Code | LPC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | G V MEDICAL, INC, 3750 Annapolis Ln. minneapolis, MN 55441 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870071 | Original Filing | |
| S008 | 1990-10-16 | Normal 180 Day Track |
| S007 | 1990-01-11 | Normal 180 Day Track |
| S006 | 1989-08-22 | Normal 180 Day Track |
| S005 | 1989-03-13 | Normal 180 Day Track |
| S004 | 1988-12-12 | Normal 180 Day Track |
| S003 | 1988-12-12 | Normal 180 Day Track |
| S002 | 1988-12-12 | Normal 180 Day Track |
| S001 | 1988-12-12 | Normal 180 Day Track |