Proclaim DRG IPG
FDA premarket approval P150004/S052 · decided 2023-11-27
Approval details
- PMA number
- P150004
- Supplement
- S052
- Supplement type
- Real-Time Process
- 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
- 2021-09-10
- Decision date
- 2023-11-27
- Days to decision
- 808 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- This supplement requested approval for qualifying an alternate supplier (ProMed) for the existing components split septum and header seals of the ProClaim Dorsal Root Ganglion (DRG) Stimulation Implantable Pulse Generator (IPG).
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