PMA P030054S150
- Device
- QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S150
- Product code
- NIK
- Decision date
- 2015-08-13
- 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 MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
Current openFDA PMA Record#
- Device
- QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S150
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2015-08-13
- Decision code
- APPR
- Date received
- 2010-05-20
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.