Cassette and Cassette Spacer
FDA premarket approval P150004/S013 · decided 2017-08-24
Approval details
- PMA number
- P150004
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cassette and Cassette Spacer
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-08-22
- Decision date
- 2017-08-24
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- New equipment at an alternate supplier manufacturing location for the cassette and cassette spacer components of the dorsal root ganglion (DRG) implantable pulse generators (IPGs).
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