PMA P870076S024

Device: Trocar Knife
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S024
Product code: KNH
Decision date: 2020-02-12
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: Qualification of a new supplier of the Trocar Knife (part number 004556-503) to assure that it will continue to meet the previously approved specifications for this component. The Trocar Knife is currently supplied by XL Precision and was proposed to be supplied by the new supplier RMS Surgical.

Current openFDA PMA Record#

Device: Trocar Knife
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S024
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2020-02-12
Decision code: OK30
Date received: 2020-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of a new supplier of the Trocar Knife (part number 004556-503) to assure that it will continue to meet the previously approved specifications for this component. The Trocar Knife is currently supplied by XL Precision and was proposed to be supplied by the new supplier RMS Surgical.