Proclaim Spinal Cord Stimulation (SCS) IPG Family
FDA premarket approval P010032/S151 · decided 2019-09-09
Approval details
- PMA number
- P010032
- Supplement
- S151
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Proclaim Spinal Cord Stimulation (SCS) IPG Family
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-06-12
- Decision date
- 2019-09-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for rebranding the Proclaim Elite device to the Proclaim XR and for changing the company name from SJM to Abbott and approval for revising the labeling to include additional cycling parameters within previously approved cycling range on the 36600, 3661, 3662, and 3663 Proclaim Implanted Pulse Generator models.
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