PMA P030054S212
- Device
- SJM CRTDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S212
- Product code
- NIK
- Decision date
- 2012-05-10
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA.
Current openFDA PMA Record#
- Device
- SJM CRTDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S212
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-05-10
- Decision code
- APPR
- Date received
- 2011-12-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA.