CONTAK RENEWAL 3
FDA premarket approval P010012/S095 · decided 2006-01-20
Approval details
- PMA number
- P010012
- Supplement
- S095
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTAK RENEWAL 3
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2005-12-21
- Decision date
- 2006-01-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- UPDATE THE HYBRID TEST SOFTWARE INCORPORATING MODIFICATIONS TO SEVERAL DEVICE FUNCTIONAL TESTS.
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510(k) clearances by this applicant
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|---|---|---|
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |