PMA P010059S006
- Device
- FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
- Applicant
- Morcher GmbH
- PMA number
- P010059
- Supplement
- S006
- Product code
- MRJ
- Decision date
- 2017-01-26
- Generic name
- Ring, endocapsular
- Approval order statement
- Approval for new private labeling for an alternative distributor.
Current openFDA PMA Record#
- Device
- FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
- Applicant
- Morcher GmbH
- PMA number
- P010059
- Supplement
- S006
- Product code
- MRJ
- Generic name
- Ring, endocapsular
- Decision date
- 2017-01-26
- Decision code
- APPR
- Date received
- 2016-08-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for new private labeling for an alternative distributor.