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 | NON-ABSORBABLE BLACK SILK SUTURE |
Generic Name | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
Applicant | LOOK, INC. |
Date Received | 1990-07-31 |
Decision Date | 1990-09-12 |
PMA | N83074 |
Supplement | S004 |
Product Code | CAP |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | LOOK, INC. 2020 Lonnie Abbott Ind. Blvd. ada, OK 74820 |
Supplement Number | Date | Supplement Type |
---|---|---|
N83074 | Original Filing | |
S004 | 1990-07-31 | Normal 180 Day Track |
S003 | ||
S002 | 1986-03-21 | |
S001 | 1984-07-10 |