PMA P880086S216
- Device
- IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, & ACCENT FAMILIES OF IPG'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S216
- Product code
- NVZ
- Decision date
- 2012-04-13
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, & ACCENT FAMILIES OF IPG'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S216
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2012-04-13
- Decision code
- APPR
- Date received
- 2012-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.