ORCOLON (R) (POLYACRYLAMIDE)

FDA Premarket Approval P900010 S001

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.

Pre-market Approval Supplement Details

DeviceORCOLON (R) (POLYACRYLAMIDE)
Generic NameAid, Surgical, Viscoelastic
ApplicantOPTICAL RADIATION CORP.
Date Received1991-05-14
Decision Date1991-07-03
PMAP900010
SupplementS001
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address OPTICAL RADIATION CORP. 1300 Optical Dr. azusa, CA 91702

Supplemental Filings

Supplement NumberDateSupplement Type
P900010Original Filing
S002 1991-06-12 Normal 180 Day Track
S001 1991-05-14 Normal 180 Day Track

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