|
Device | KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM |
Generic Name | Light source system, diagnostic endoscopic |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. EL SEGUNDO, CA 90245 |
PMA Number | P050027 |
Supplement Number | S004 |
Date Received | 08/21/2012 |
Decision Date | 09/10/2012 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL OF CORRECTIONS TO THE ETHYLENE OXIDE (ETO) STERILIZATION INSTRUCTIONS CONTAINED IN THE PDD CAMERA HEADS INSTRUCTION CARD, HOPKINS II PDD TELESCOPES INSTRUCTION MANUAL AND TRICAM SL II CAMERA CONTROL UNIT INSTRUCTION MANUAL. |