PMA P870076S008

Device: ACMI FALOPE RING BAND
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S008
Product code: KNH
Decision date: 2007-05-24
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT GYRUS ACMI CORPORATION, MAPLE GROVE MINNESOTA TO MANUFACTURE THE FALOPE RING BAND AND THE FALOPE RING BAND DISPOSABLE APPLICATOR KITS.

Current openFDA PMA Record#

Device: ACMI FALOPE RING BAND
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S008
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2007-05-24
Decision code: APPR
Date received: 2006-08-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT GYRUS ACMI CORPORATION, MAPLE GROVE MINNESOTA TO MANUFACTURE THE FALOPE RING BAND AND THE FALOPE RING BAND DISPOSABLE APPLICATOR KITS.