FRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE
FDA premarket approval P030035/S001 · decided 2004-08-16
Approval details
- PMA number
- P030035
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2004-07-21
- Decision date
- 2004-08-16
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE FRONTIER II MODEL 5586 BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE.
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