PRODIGY SR, ENRHYTHM IPG MODEL P150DR
FDA premarket approval P890003/S156 · decided 2008-12-11
Approval details
- PMA number
- P890003
- Supplement
- S156
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRODIGY SR, ENRHYTHM IPG MODEL P150DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2008-11-12
- Decision date
- 2008-12-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- NEW SPRAY WASH EQUIPMENT AND MODIFICATION OF THE BARB FASTENER AND PIN/STRAP CLEANING PROCESS.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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