PMA P870076S015
- Device
- DISPOSABLE FALOPE RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S015
- Product code
- KNH
- Decision date
- 2014-12-04
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- ADJUSTMENT OF THE SEALING PARAMETERS AND THE REPEAT OF A PEEL STRENGTH TEST AND VISUAL CHECK.
Current openFDA PMA Record#
- Device
- DISPOSABLE FALOPE RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S015
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2014-12-04
- Decision code
- OK30
- Date received
- 2014-11-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADJUSTMENT OF THE SEALING PARAMETERS AND THE REPEAT OF A PEEL STRENGTH TEST AND VISUAL CHECK.