PMA P150004S075
- Device
- DRG Delivery Sheath
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S075
- Product code
- PMP
- Decision date
- 2024-07-17
- Classification
- Neurology
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Approval order statement
- relocation of a subset of a second-tier supplier's manufacturing process for a component of the DRG Delivery Sheath to increase supplier production capacity
Current openFDA PMA Record#
- Device
- DRG Delivery Sheath
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S075
- Product code
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Decision date
- 2024-07-17
- Decision code
- OK30
- Date received
- 2024-06-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- relocation of a subset of a second-tier supplier's manufacturing process for a component of the DRG Delivery Sheath to increase supplier production capacity