PMA P150030S008
- Device
- R3 Biolox delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S008
- Product code
- MRA
- Decision date
- 2020-08-21
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Approval of a revised protocol for the post-approval study protocol.
Current openFDA PMA Record#
- Device
- R3 Biolox delta Ceramic Acetabular System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P150030
- Supplement
- S008
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2020-08-21
- Decision code
- APPR
- Date received
- 2020-07-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of a revised protocol for the post-approval study protocol.