Proclaim Dorsal Root Ganglion (DRG) IPG
FDA premarket approval P150004/S083 · decided 2025-02-21
Approval details
- PMA number
- P150004
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Proclaim Dorsal Root Ganglion (DRG) IPG
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-02-05
- Decision date
- 2025-02-21
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- to qualify an additional production line at a new manufacturing site in Huizhou, China, for the purposes of completing the backend processing of resistors used in the hybrid component of Abbotts Orion and Gemini implantable pulse generators
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510(k) clearances by this applicant
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|---|---|---|
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |