Proclaim DRG IPG
FDA premarket approval P150004/S025 · decided 2018-09-19
Approval details
- PMA number
- P150004
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Proclaim DRG IPG
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-08-20
- Decision date
- 2018-09-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Updated design of the Manufacturing Test Lead which is used for testing the Proclaim Dorsal Root Ganglion Implantable Pulse Generator during the manufacturing process.
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