|
Device | ISPAN TM PERFLUOROPROPANE (C3F8)GAS |
Generic Name | Gases used within eye to place pressure on detached retina |
Regulation Number | 886.4270 |
Applicant | Airgas Therapeutics LLC 6141 Easton Road Plumsteadville, PA 18949 |
PMA Number | P900066 |
Supplement Number | S002 |
Date Received | 08/23/1996 |
Decision Date | 09/24/1996 |
Product Code |
LPO |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A 20 GRAM AND A 125 GRAM ALUMINUM LECTURE BOTTLE SIZE FOR THE REFERENCED DEVICES. |