PMA P880086S234
- Device
- ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S234
- Product code
- NVZ
- Decision date
- 2013-09-05
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGE IN THE ENCAPSULATION CURE PROCESS FOR THE LEFT VENTRICULAR RADIOFREQUENCY (LV RF) MODULES IN THE DEVICES.
Current openFDA PMA Record#
- Device
- ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S234
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2013-09-05
- Decision code
- OK30
- Date received
- 2013-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE ENCAPSULATION CURE PROCESS FOR THE LEFT VENTRICULAR RADIOFREQUENCY (LV RF) MODULES IN THE DEVICES.