PMA P950022S130
- Device
- Durata, Optisure
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S130
- Product code
- LWS
- Decision date
- 2020-03-26
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the dexamethasone and total impurities specification limits for annual stability testing.
Current openFDA PMA Record#
- Device
- Durata, Optisure
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S130
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-03-26
- Decision code
- OK30
- Date received
- 2020-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the dexamethasone and total impurities specification limits for annual stability testing.