PMA P090002S006

Device
PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant
DePuy Orthopaedics, Inc.
PMA number
P090002
Supplement
S006
Product code
OVO
Decision date
2012-11-20
Generic name
Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Approval order statement
CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS.

Current openFDA PMA Record#

Device
PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant
DePuy Orthopaedics, Inc.
PMA number
P090002
Supplement
S006
Product code
OVO
Generic name
Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
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.