OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

FDA premarket approval P940010/S011 · decided 2014-03-21

Approval details

PMA number

P940010

Supplement

S011

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

Generic name

System, laser, fiber optic, photodynamic therapy

Applicant

Pinnacle Biologics, Inc.

Date received

2013-09-13

Decision date

2014-03-21

Days to decision

189 days

Decision code

APPR

Product code

MVG

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Bannockburn, IL

Statement

APPROVAL FOR:1) A CHANGE IN THE MATERIAL OF THE TUBING CAP PLACED OVER THE DIFFUSER TIP FROM A POLYCARBONATEMATERIAL TO AN ETFE TUBING MATERIAL;2) THE USE OF HEAT BONDING FOR THE ETFE TUBING MATERIAL IN PLACE OF THE ADHESIVE BONDING PRESENTLY USED FOR THE TUBING CAP;3) ELIMINATION OF THE ORANGE SHEATH PRESENTLY ADDED OVER THE INACTIVE LENGTH OF THE PRESENTLYMARKETED FIBER OPTIC DIFFUSERS; AND4) MODIFICATION OF THE DIFFUSER TIP, SPECIFICALLY:A) USE OF A SILVER MIRROR TO REPLACE THE DIELECTRIC MAT