PMA P030017S098
- Device
- PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S098
- Product code
- LGW
- Decision date
- 2010-05-06
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR A CONSOLIDATION OF THREE SEPARATE INSTRUCTION MANUALS (I.E., PHYSICIAN IMPLANT, PHYSICIAN LEAD, AND PHYSICIAN SURGICAL LEAD MANUALS) INTO A SINGLE MANUAL, THE PHYSICIAN SYSTEM CLINICAL MANUAL.
Current openFDA PMA Record#
- Device
- PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S098
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2010-05-06
- Decision code
- APPR
- Date received
- 2010-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CONSOLIDATION OF THREE SEPARATE INSTRUCTION MANUALS (I.E., PHYSICIAN IMPLANT, PHYSICIAN LEAD, AND PHYSICIAN SURGICAL LEAD MANUALS) INTO A SINGLE MANUAL, THE PHYSICIAN SYSTEM CLINICAL MANUAL.