PMA P010032S099
- Device
- SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S099
- Product code
- LGW
- Decision date
- 2015-09-10
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- ACCEPTANCE OF REPLACING AN EXISTING CENTERLESS GRINDER (GLEBAR TF-9DHD) WITH A NEW CENTERLESS GRINDER (GLEBAR GT-9DHD) USED DURING THE MANUFACTURING OF SCS LEADS, DBS LEADS, AND TERMINAL END SUBASSEMBLIES.
Current openFDA PMA Record#
- Device
- SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S099
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-09-10
- Decision code
- OK30
- Date received
- 2015-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ACCEPTANCE OF REPLACING AN EXISTING CENTERLESS GRINDER (GLEBAR TF-9DHD) WITH A NEW CENTERLESS GRINDER (GLEBAR GT-9DHD) USED DURING THE MANUFACTURING OF SCS LEADS, DBS LEADS, AND TERMINAL END SUBASSEMBLIES.