PMA P880006S034
- Device
- REGENCY SC+ PULSE GENERATORS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S034
- Product code
- KRG
- Decision date
- 2001-10-25
- Classification
- Cardiovascular
- Generic name
- Programmer, pacemaker
- Approval order statement
- ELIMINATION OF THE IN-PROCESS X-RAY IMAGING OF THE MICRONY AND REGENCY SC+ PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- REGENCY SC+ PULSE GENERATORS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S034
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 2001-10-25
- Decision code
- OK30
- Date received
- 2001-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF THE IN-PROCESS X-RAY IMAGING OF THE MICRONY AND REGENCY SC+ PULSE GENERATORS.