PMA P040006S001
- Device
- CHARITE ARTIFICIAL DISC
- Applicant
- Depuy Spine, Inc.
- PMA number
- P040006
- Supplement
- S001
- Product code
- MJO
- Decision date
- 2005-06-16
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITES LOCATED AT DEPUY (IRELAND) LTD, CORK, IRELAND, FOR MANUFACTURING AND ISOTRON PLC, MARCUS CLOSE, BERKSHIRE, UNITED KINGDOM, FOR STERILIZATION.
Current openFDA PMA Record#
- Device
- CHARITE ARTIFICIAL DISC
- Applicant
- Depuy Spine, Inc.
- PMA number
- P040006
- Supplement
- S001
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2005-06-16
- Decision code
- APPR
- Date received
- 2005-01-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITES LOCATED AT DEPUY (IRELAND) LTD, CORK, IRELAND, FOR MANUFACTURING AND ISOTRON PLC, MARCUS CLOSE, BERKSHIRE, UNITED KINGDOM, FOR STERILIZATION.