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Trade Name | Fetoscopy Instruments |
Classification Name | amnioscope, transabdominal (fetoscope) (and accessories) |
Generic Name | amnioscope, transabdominal (fetoscope) (and accessories) |
Regulation Number | 884.1600 |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 e. grand ave. |
el segundo, CA 90245 |
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HDE Number | H040005 |
Supplement Number | S007 |
Date Received | 01/21/2022 |
Decision Date | 02/18/2022 |
Product Code | |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | special (immediate track) |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modification to the ifu and patient brochure to include additional details on pseudo amniotic band syndrome and outcomes associated with it. |