PACEMAKER AND CRT-P DEVICES
FDA premarket approval P880086/S205 · decided 2011-07-22
Approval details
- PMA number
- P880086
- Supplement
- S205
- Trade name
- PACEMAKER AND CRT-P DEVICES
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-06-08
- Decision date
- 2011-07-22
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A CHANGE TO THE SEAL PLUG FOR THE SETSCREW (REFERRED TO AS THE SEPTUM IN THE SUBMISSION).
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