REPLY DR & SR
FDA premarket approval P950029/S042 · decided 2009-04-02
Approval details
- PMA number
- P950029
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- REPLY DR & SR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-03-04
- Decision date
- 2009-04-02
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE REPLY DR AND REPLY SR IMPLANT MANUALS.
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