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STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

FDA premarket approval P990013/S017 · decided 2008-04-24

Approval details

PMA number
P990013
Supplement
S017
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic name
intraocular lens
Applicant
Starr Surgical Co.
Date received
2008-03-28
Decision date
2008-04-24
Days to decision
27 days
Decision code
OK30
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Monrovia, CA
Statement
NEW MEASUREMENT MODIFICATION TO THE LATHING PROCESS.

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