Note: 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. |
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Device | LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER |
Generic Name | Catheter, balloon for retinal reattachment |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P820009 |
Supplement Number | S003 |
Date Received | 08/15/1986 |
Decision Date | 09/18/1986 |
Withdrawal Date
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01/23/2015 |
Product Code |
LOG |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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