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 |
Generic Name | Device, Angioplasty, Laser, Coronary |
Applicant | G V MEDICAL, INC, |
Date Received | 1990-10-16 |
Decision Date | 1991-08-06 |
PMA | P870071 |
Supplement | S008 |
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 |