PMA P040023
- Device
- DURALOC OPTION CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P040023
- Supplement
- S025
- Product code
- MRA
- Decision date
- 2012-11-20
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS.
Current openFDA PMA Record#
- Device
- DURALOC OPTION CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P040023
- Supplement
- S025
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-11-20
- Decision code
- OK30
- Date received
- 2012-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS.