PMA P880006S086
- Device
- REGENCY, SENSLOG AND DIALOG
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S086
- Product code
- NIK
- Decision date
- 2013-05-14
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
Current openFDA PMA Record
- Device
- REGENCY, SENSLOG AND DIALOG
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S086
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2013-05-14
- Decision code
- OK30
- Date received
- 2013-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.