PMA P880006S083
- Device
- Regency
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S083
- Decision date
- 2012-10-10
Current openFDA PMA Record
- Device
- REGENCY
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S083
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-10-10
- Decision code
- OK30
- Date received
- 2012-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.