PMA P010018S007

Device
VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM
Applicant
Refractec, Inc.
PMA number
P010018
Supplement
S007
Product code
MWD
Decision date
2005-03-22
Classification
Ophthalmic
Generic name
Electrosurgical, radio frequency, refractive correction
Approval order statement
ALTERNATE MANUFACTURING METHOD FOR THE TROCAR AND STOP SUBASSEMBLY OF THE DISPOSABLE KERATOPLAST TIP.

Current openFDA PMA Record#

Device
VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM
Applicant
Refractec, Inc.
PMA number
P010018
Supplement
S007
Product code
MWD
Generic name
Electrosurgical, radio frequency, refractive correction
Decision date
2005-03-22
Decision code
OK30
Date received
2005-02-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE MANUFACTURING METHOD FOR THE TROCAR AND STOP SUBASSEMBLY OF THE DISPOSABLE KERATOPLAST TIP.