MEDTRONIC INDURA 1P ONE PIECE INTRATHECAL CATHETER
FDA premarket approval P860004/S039 · decided 1998-05-21
Approval details
- PMA number
- P860004
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INDURA 1P ONE PIECE INTRATHECAL CATHETER
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 1997-11-25
- Decision date
- 1998-05-21
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for implementation of the Medtronic(R) InDura(R) 1P One Piece Intrathecal Catheter Model 8709 with your SynchroMed(TM) Infusion System.
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