PMA P950022S087
- Device
- DURATA FAMILY OF HIGH VOLTAGE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S087
- Product code
- NVY
- Decision date
- 2014-10-27
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- ADD AN ALTERNATE AIR STRINGING PROCESS FOR THE CABLES USED IN THE LEADS.
Current openFDA PMA Record#
- Device
- DURATA FAMILY OF HIGH VOLTAGE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S087
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2014-10-27
- Decision code
- OK30
- Date received
- 2014-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ALTERNATE AIR STRINGING PROCESS FOR THE CABLES USED IN THE LEADS.