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 | ~[24~R DIRECT CURRENT BONE GROWTH STIMULATOR |
Generic Name | Stimulator, Invasive Bone Growth |
Applicant | ZIMMER, INC. |
Date Received | 1989-09-06 |
Decision Date | 1991-03-29 |
PMA | P790008 |
Supplement | S005 |
Product Code | LOE |
Advisory Committee | Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 |
Supplement Number | Date | Supplement Type |
---|---|---|
P790008 | Original Filing | |
S005 | 1989-09-06 | Normal 180 Day Track |
S004 | 1988-03-02 | 30-Day Supplement |
S003 | 1982-07-29 | Normal 180 Day Track |
S002 | ||
S001 | 1982-03-08 | Normal 180 Day Track |