|
Device | PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY |
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 | S006 |
Date Received | 08/13/2002 |
Decision Date | 12/10/2002 |
Product Code |
LPO |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A MOLECULAR SIEVE SCRUBBING STEP AT THE END OF THE GAS MANUFACTURING PROCESS. |