PMA P960030S037
- Device
- ISOFLEX P, ISOFLEX OPTIM, ISOFLEX S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960030
- Supplement
- S037
- Product code
- NVY
- Decision date
- 2012-10-10
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
Current openFDA PMA Record#
- Device
- ISOFLEX P, ISOFLEX OPTIM, ISOFLEX S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960030
- Supplement
- S037
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2012-10-10
- Decision code
- OK30
- Date received
- 2012-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.