PMA P870076S019
- Device
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S019
- Product code
- KNH
- Decision date
- 2016-01-27
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- CHANGE IN SUPPLIERS FROM SENIOR OPERATIONS LLC (FORMERLY KNOWN AS GORMAC PRODUCTS) TO GYRUS ACMI NORWALK, OH FACILITY (ESTABLISHMENT REGISTRATION NUMBER 1519132) FOR THE MANUFACTURE OF THE FOLLOWING COMPONENTS OF YOUR DEVICE: FALOPE RING BAND APPLICATOR FORCEPS INNER TUBE (PART NUMBER 005261); OUTER TUBE (PART NUMBER 005262); AND CANNULA SLEEVE (PART NUMBER 004557-3).
Current openFDA PMA Record#
- Device
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S019
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2016-01-27
- Decision code
- OK30
- Date received
- 2015-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN SUPPLIERS FROM SENIOR OPERATIONS LLC (FORMERLY KNOWN AS GORMAC PRODUCTS) TO GYRUS ACMI NORWALK, OH FACILITY (ESTABLISHMENT REGISTRATION NUMBER 1519132) FOR THE MANUFACTURE OF THE FOLLOWING COMPONENTS OF YOUR DEVICE: FALOPE RING BAND APPLICATOR FORCEPS INNER TUBE (PART NUMBER 005261); OUTER TUBE (PART NUMBER 005262); AND CANNULA SLEEVE (PART NUMBER 004557-3).