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 | HEATCASE(TM) |
Generic Name | Sterilizer, Soft-lens, Thermal, Ac-powered |
Applicant | WESLEY JESSEN CORP. |
Date Received | 1983-12-09 |
Decision Date | 1984-01-18 |
PMA | P830001 |
Supplement | S002 |
Product Code | HRD |
Advisory Committee | Ophthalmic |
Expedited Review | No |
Combination Product | No |
Applicant Address | WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610 |
Supplement Number | Date | Supplement Type |
---|---|---|
P830001 | Original Filing | |
S002 | 1983-12-09 | |
S001 | 1983-11-14 |