PINNACLE PELVIC FLOOR REPAIR KIT II


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed

510(k) Number K081048
Device Name PINNACLE PELVIC FLOOR REPAIR KIT II
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact michelle barry
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact michelle barry
Regulation Number 878.3300
Classification Product Code
OTP  
Date Received 04/14/2008
Decision Date 08/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No