|Trade Name||PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY|
|Classification Name||gases used within eye to place pressure on detached retina|
|Applicant||SCOTT MEDICAL PRODUCTS GROUP|
|Supplement Type|| Special Supplement|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the toxicity test protocol to increase the number of samples to be tested from each production lot of perfluoropropane from one sample per lot to three samples per lot.